LICENSE TO OPERATE

32
1.LICENSE TO OPERATE OF ESTABLISHMENT
This process details the issuance of License to Operate (LTO) to establishments in the country. Establishments engaged in the manufacture,
importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health
product are required to secure a LTO from the FDA.

1.1.LICENSE TO OPERATE – INITIAL APPLICATION FOR DRUG MANUFACTURERS

Center/Office/Division : Center for Drug Regulation and Research (CDRR)

Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Drug Products
Fees to be Paid : Drug Manufacturer:
20 Million and below - Php 10,000 +1 % LRF per year
Over 20 Million but below 50 Million - Php 15,000 +1 % LRF per year
50 Million and above - Php 20,000 +1 % LRF per year

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1) Basic Requirements based on the Administrative Order No. 2020-0017: FDA website (www.fda.gov.ph)

33
Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal System
● Location plan and Global Positioning System (GPS) coordinates to be filled in the eApplication Form
● Name of the Qualified Person depending on the type of health product establishment
● Self-Declaration in the e-Application Form
2) Proof of Business Registration
Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade
and Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the
Securities and Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles of
Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with original
charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC)
and Articles of Incorporation, if without original charter (1 Scanned copy PDF)

When a business or establishment address is different from the business name registration address,
the applicant shall submit a copy of the Business Permit (e.g., Mayor’s Permit).
3) Proof of income (Latest Audited Financial Statement with Balance Sheet) or Duly notarized
Statement/Certification of Initial Capitalization.
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

5) Site Master File (shall be presented to the FDA inspectors during inspection)
6) Risk Management Plan (shall be presented to the FDA inspectors during inspection)
7) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be presented to
the FDA inspectors during inspection

34
 CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON
BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal for FDA Cashier
using the issued username and password, and confirmed payments. This will Administrative
uploads the required documentary requirements prompt automatic decking of and Finance
(in PDF format) for e-LTO application application to respective RFO. Service

Downloads and prints the generated Order of See above

LBP OnColl Payment: 5 wd
Payment through the ePortal System and email table
Other Payment Channels: 2 wd
notification.

Pays the assessed fee as per the system-

generated Order of Payment through the
existing payment channels
1.2 Conducts pre-licensing Regional Field
inspection Officer/ Inspector

Refer to Regional Field Office

(RFO) Citizen’s Charter for the None
issuance of Certificate of
Compliance /Recommendation
for Disapproval/
Recommendation Letter.
1.3 Evaluates completeness and FDA Evaluator
13 working (Center/Licensing
veracity of the documents None
days and Registration)
submitted.
1.4 Checks evaluation and veracity 3 working Technical Officer
of documents submitted. None of Center
days
35
 1.5 Quality assurance of the Technical Officer
evaluation. None 1 working day of Center

1.6 Finalizes decision on the LTO Center Director

application
3 working days
If application is disapproved, the None
applicant will be notified through
email and will receive the Letter of
Denial
2. Receives notification and link of LTO for printing Qualified Person
TOTAL: 20 working
days

36
1.2.LICENSE TO OPERATE – RENEWAL APPLICATION FOR DRUG MANUFACTURERS

Center/Office/Division : Center for Drug Regulation and Research (CDRR)

Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Drug Products
Fees to be Paid : Drug Manufacturer:
20 Million and below - Php 30,000 +1 % LRF
over 20 Million but below 50 Million - Php 45,000 +1 % LRF
50 Million and above - Php 60,000 +1 % LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-004

Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License
of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3,
Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing
Rules and Regulations, and Other Purposes

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

37
1) Basic Requirements based on the Administrative Order No. 2020-0017: FDA website (www.fda.gov.ph)
● Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal (www.fda.gov.ph)
● Declaration and Undertaking
2) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

3) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal System 1.1 Posts payment in ePortal for See above FDA Cashier
(http://eportal.fda.gov.ph) using the issued confirmed payments. This will table Administrative
username and password, and uploads the prompt automatic decking of and Finance
required documentary requirements (in PDF) application to respective Service
for e-LTO application Center/Office

Downloads and prints the generated Order of

LBP OnColl Payment : 5 wd
Payment through the ePortal and Email
Other Payment Channels : 2 wd
notification

Pays the assessed fee as per the system-

generated Order of Payment through the
existing payment channels

1.2 Conducts inspection (if None Regional Field

necessary) Officer/ Inspector

38
 Refer to Regional Field Office
Citizen’s Charter for the issuance of
Certificate of Compliance/
Recommendation for Disapproval/
Recommendation Letter
1.3 Evaluates completeness and None 3 working FDA Evaluator
veracity of the documents days (Center/Licensing
submitted and Registration
1.4 Checks evaluation and veracity of None 1 working day Technical Officer
documents submitted. of Center

1.5 Quality assurance of the None 1 working day Technical Officer

evaluation. of Center

1.6 Finalizes decision on the None 2 working Center Director

Approval of LTO days

If application is disapproved, the

applicant will be notified through
email and will receive the Letter of
Denial
2. Receives notification and link of LTO for printing None Qualified Person
TOTAL: 7 Working
Days

39
1.3.LICENSE TO OPERATE – MAJOR VARIATION APPLICATION FOR DRUG ESTABLISHMENT (MANUFACTURERS)

Center/Office/Division : Center for Drug Regulation and Research (CDRR)

Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Drug Manufacturers
Fees to be Paid : Major Variation: Php 500 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS (based on Administrative Order No. 2020-0017) WHERE TO SECURE

Major Variation FDA ePortal System
(www.fda.gov.ph)
Transfer of Location of Manufacturing Plant
- Accomplished e-Application Form
- Business permit reflecting the new address
- Updated Site Master File to be presented upon inspection
- Payment of fees
Expansion of Manufacturer and/or Additional Product Line; or Change of Manufacturing Activity
- Accomplished e-Application Form
- Updated Site Master File to be presented upon inspection

40
- Payment of fees

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal for FDA Cashier
using the issued username and password, and confirmed payments. This will Administrative
uploads the required documentary requirements (in prompt automatic decking of and Finance
PDF format) for e-LTO application application to respective RFO. Service

Downloads and prints the generated Order of See above

LBP OnColl Payment: 5 wd
Payment through the ePortal System and table
Other Payment Channels:
email notification.
2 wd
Pays the assessed fee as per the system-
generated Order of Payment through the
existing payment channels
1.2 Conducts inspection Regional Field
Officer/
Refer to Regional Field Office Inspector
(RFO) Citizen’s Charter for the
None
issuance of Certificate of
Compliance /Recommendation
for Disapproval/
Recommendation Letter.
1.3 Evaluates completeness and FDA Evaluator
None 13 working days (Center/Licensing
and Registration)
41
 veracity of the documents
submitted.
1.4 Checks evaluation and Technical Officer
3 working
veracity of documents None of Center
days
submitted.
1.5 Quality assurance of the Technical Officer
evaluation. None 1 working day of Center

1.6 Finalizes decision on the LTO Center Director

application
3 working days
If application is disapproved, the None
applicant will be notified through
email and will receive the Letter
of Denial
2. Receives notification and link of LTO for printing Qualified Person
TOTAL: 20 working
days

42
1.4.LICENSE TO OPERATE – INITIAL APPLICATION FOR DRUG TRADERS, DRUG DISTRIBUTORS (IMPORTER, EXPORTER,
WHOLESALER), DRUGSTORES, RETAIL OUTLETS FOR NON-PRESCRIPTION DRUGS (RONPD), CLINICAL RESEARCH
ORGANIZATIONS AND SPONSORS

Center/Office/Division : Center for Drug Regulation and Research (CDRR)

Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Drug Traders, Drug Distributors (Importer, Exporter, Wholesaler), Drugstores/Retail Outlets for Non-
Prescription Drugs, Clinical Research Organizations and Sponsors
Fees to be Paid : Drug Traders:
20 Million and below – Php 3,000 + 1% LRF per year
over 20 Million but below 50 Million – Php 5,000 + 1% LRF per year
50 Million and above – Php 7,000 + 1% LRF per year

Drug Distributors:
Importer, Exporter, Wholesaler- Php 5,000 + 1% LRF per year

Drug Outlets:
Drugstore and Retail Outlet for Non-Prescription Drugs - Php 1,000 + 1% LRF per year

Clinical Research Organizations and Sponsors :

20 Million and below – Php 3,000 + 1% LRF per year
over 20 Million but below 50 Million – Php 5,000 + 1% LRF per year
50 Million and above – Php 7,000 + 1% LRF per year

43
 Administrative Order 50 s. 2001
Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1)Basic Requirements based on the Administrative Order No. 2020-0017: FDA website (www.fda.gov.ph)
Accomplished e-Application Form as prescribed by FDA regulations. FDA eServices
● Location plan and Global Positioning System (GPS) coordinates to be filled in the e-Application Form (www.fda.gov.ph)
● Name of the Qualified Person depending on the type of health product establishment Self-Declaration in
the e-Application Form

2) Proof of Business Registration

Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade and
Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the
Securities and
Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles of
Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with original
charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC) and
Articles of Incorporation, if without original charter (1 Scanned copy PDF)

44
When a business or establishment address is different from the business name registration address, the
applicant shall submit a copy of the Business Permit (e.g., Mayor’s Permit).

3) Proof of income (for Trader) - Latest Audited Financial Statement with Balance Sheet or Duly notarized
Statement/Certification of Initial Capitalization.
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

5) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be presented to the
FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1. Conducts pre-assessment on the FDA Evaluator
http://eservices.fda.gov.ph and click submitted application and (Center/Licensing
“Applications“ found on the upper right corner documentary requirements with and Registration)
of the system.
regards to completeness and
Selects the product category (Drug) and the type correctness.
of business establishment (Drug Trader, Drug
Distributor, Drugstores, RONPD, CRO, Sponsor) If the application passed the pre-
before clicking “Initial” Application assessment step, the applicant
None
shall receive the Order of
Fills-out all necessary information. All fields mark
with asterisk (*) are required to be filled-out. Payment with Reference
Number via email.
Uploads the required documents as indicated on
the Checklist of Requirements in pdf format. If not, the FDA shall notify the
client the reason/s for non-
Reviews the duly filled out form in the Self-
Assessment Review. Once reviewed, click on acceptance and prompt the
“Confirm” to submit the application.

45
 applicant to apply again through
the eServices Portal.
2. Prints the Order of Payment with Reference 2. Posts payment in eServices FDA Cashier
Number sent through the declared e-mail address Portal System for confirmed Administrative
payments. This will prompt and Finance
Pays the application fee through existing payment
automatic decking of Service (AFS)
channels
application to respective
Center.

LBP OnColl Payment:

5 wd See above
Other Payment Channels: table
2 wd

Note: Acknowledgement
Receipt will automatically be
sent to the client once payment
is posted and will signify the
start of processing time of the
application.
3. Receives Acknowledgement Receipt through 3.1 Checks and quality assurance Technical Officer
email of the documents provided None 4 working days of Center

3.2 Finalizes decision on the LTO

application
None 3 working days Center Director
If application is approved, the
FDA shall send the LTO to the
46
 registered email address of the
applicant.

If application is disapproved,
the FDA shall inform the
applicant through its registered
email address of the reason for
such action on the application.
4. Receives notification and prints LTO if Qualified Person
application is approved
TOTAL: 7 working days

47
1.5.LICENSE TO OPERATE – RENEWAL APPLICATION FOR DRUG TRADERS, DRUG DISTRIBUTORS (IMPORTER, EXPORTER,
WHOLESALER), DRUGSTORES, RETAIL OUTLETS FOR NON-PRESCRIPTION DRUGS (RONPD), CLINICAL RESEARCH
ORGANIZATIONS AND SPONSORS

Center/Office/Division : Center for Drug Regulation and Research (CDRR)

Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : All Drug Traders, Drug Distributors (Importer, Exporter, Wholesaler), Drugstores/Retail Outlets for Non-
Prescription Drugs, Clinical Research Organizations and Sponsors
Fees to be Paid : Drug Traders:
20 Million and below – Php 9,000 + 1% LRF
over 20 Million but below 50 Million – Php 15,000 + 1% LRF
50 Million and above – Php 21,000 + 1% LRF

Drug Distributors:
Importer, Exporter, Wholesaler- Php 15,000 + 1% LRF

Drug Outlets:
Drugstore and Retail Outlet for Non-Prescription Drugs - Php 3,000 + 1% LRF

Clinical Research Organizations and Sponsors :

20 Million and below – Php 9,000 + 1% LRF
over 20 Million but below 50 Million – Php 15,000 + 1% LRF
50 Million and above – Php 21,000 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of

48
 Food and Drugs

FDA Circular No. 2011-004

Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License
of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3,
Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing
Rules and Regulations, and Other Purposes

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1) Basic Requirements based on the Administrative Order No. 2020-0017: FDA Website (www.fda.gov.ph)
● Accomplished e-Application Form as prescribed by FDA regulations. FDA eServices (www.fda.gov.ph
● Declaration and Undertaking
2) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

3) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1. Posts confirmed payments. None FDA Cashier
https://eservices.fda.gov.ph and click This will prompt automatic Administrative
“Applications” found on the upper right corner routing of application to and Finance
of the system. Center Service

LBP OnColl Payment: 5 wd

49
 Selects the product category (Drug) and the type LBP Linkbiz: auto posting
of business establishment (Drug Trader, Drug Other Payment Channels: 2
Distributor, Drugstore, RONPD, CRO, Sponsor) wd
before clicking “Renewal” application
Note: Acknowledgement
Reads the “Declaration and Undertaking” Receipt will automatically be
before proceeding with the application process. sent to the client once
Check the box “I agree to the Declaration and payment is posted and will
Undertaking” and click on “Start Application”. signify the start of processing
time of the application.
Fills-out all necessary information. All fields
mark with asterisk (8*) are required to be filled-
out.

Updates contact numbers if necessary. Click

“Next” to proceed to Self – Assessment Review

Reviews all details in the “Self-Assessment

Review”. Once reviewed, click on “Confirm” to
submit application.

Prints the Order of Payment with Reference

Number sent through the declared email
address

Pays the application fee through existing

payment channels
2. Receives Acknowledgement Receipt through 2. Finalizes decision on the None 3 working days Center Director
email LTO application

50
 If application is disapproved, the
applicant will be notified through
email and will receive the Letter
of Denial
3. Receives notification and link of LTO for None
Printing
TOTAL: 3 working days

51
1.6.LICENSE TO OPERATE – MINOR VARIATION APPLICATION FOR DRUG TRADERS, DRUG DISTRIBUTORS (IMPORTER, EXPORTER,
WHOLESALER), DRUGSTORES, RETAIL OUTLETS FOR NON-PRESCRIPTION DRUGS (RONPD), CLINICAL RESEARCH
ORGANIZATIONS AND SPONSORS

Center/Office/Division : Center for Drug Regulation and Research (CDRR)

Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Drug Traders, Drug Distributors (Importer, Exporter, Wholesaler), Drugstores/Retail Outlets for Non-
Prescription Drugs, Clinical Research Organizations and Sponsors
Fees to be Paid : Minor Variation: Php 500 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS (based on Administrative Order No. 2020-0017) WHERE TO SECURE

Minor Variation FDA website (www.fda.gov.ph)

Transfer of Location of Offices

- Accomplished e-Application Form
- Business permit reflecting new location of office
- Payment of fees

52
Transfer of Location of Drug Retailers
- Accomplished e-Application Form
- Business permit reflecting new address
- Payment of fees
Change of Distributor Activity
- Accomplished e-Application Form
- Contract Agreements showing change in activity
- Payment of fees
Transfer/Addition of Warehouse
- Accomplished e-Application Form
- Business Permit reflecting new warehouse location
- Payment of fees
Additional Drugstore Activities
- Accomplished e-Application Form
- Additional credentials of pharmacist (as applicable)
- Other documents related or specific to the additional activity, such as but not limited to:
 Adult Vaccination – Standard Operating Procedure
 Dispense Vaccines and Biologicals – Standard Operating Procedure
 Mobile Pharmacy – Standard Operating Procedure
 Online Ordering and Delivery – Standard Operating Procedure and Website Screenshot
 Sterile Compounding and Non-Sterile Complex Compounding – Standard Operating Procedure
 Other additional activities that may require appropriate regulation
- Payment of fees
Expansion of Office Establishments and Drug Retailers
- Accomplished e-Application Form
- Expansion floor plan
- Payment of fees

53
Change of Ownership
- Accomplished e-Application Form
- Business name registration reflecting new ownership
- Any proof on the transfer of ownership such as any of the following
 Deed of Sale or assignment or transfer of rights/ownership
 Memorandum of Agreement
 Notarized Affidavit of the owner, proprietor, Chairman or CEO of the establishment validating the
transfer
- Payment of fees
Change of Business Name
- Accomplished e-Application Form
- Business permit reflecting the new name
- Payment of fees
Zonal Change in Address
- Accomplished e-application Form
- Certificate of Zonal Change
- Payment of fees
Change of Qualified Person
- Accomplished e-Application Form
- Name of new qualified person
- Applicable requirements as specified in ANNEX B of AO 2020-0017
- Payment of fees
Change of Authorized Person
- Accomplished e-Application Form
- Name of new authorized person
- Updated contact details
- Payment of fees

54
 CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON
BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1. Conducts pre-assessment on CDRR Personnel
http://eservices.fda.gov.ph and click the submitted application and
“Applications “found on the upper right corner of documentary requirements with
the system.
regards to completeness and
Selects the product category (Drug) and the type correctness.
of business establishment (Drug Trader, Drug
Distributor, Drugstores, RONPD, CRO, Sponsor) If the application passed the
before clicking “Variations” pre-assessment step, the
applicant shall receive the
Reads the “Declaration and Undertaking
“before proceeding with the application process. Order of Payment with
None
Check the box “I agree to the Declaration and Reference Number via email.
Undertaking” and click on “Start Application”.
If not, the FDA shall notify the
Fills-out all necessary information. All fields mark
client the reason/s for non-
with asterisk (*) are required to be filled-out.
acceptance and prompt the
Uploads the required documents as indicated on applicant to apply again through
the Checklist of Requirements in pdf format. the eServices Portal.

Reviews the duly filled out form in the Self-

Assessment Review. Once reviewed, click on
“Confirm” to submit the application.

55
2. Prints the Order of Payment form with Reference 2. Posts payment in eServices FDA Cashier
Number sent through the declared e-mail address Portal System for confirmed Administrative
payments. This will prompt and Finance
Pays the application fee through existing payment
channels automatic decking of application Service (AFS)
to respective Center.

LBP OnColl Payment:

5 wd
See above
Other Payment Channels:
table
2 wd

Note: Acknowledgement Receipt

will automatically be sent to the
client once payment is posted and
will signify the start of processing
time of the application.

3. Receives Acknowledgement Receipt through 3.1 Checks and quality assurance Technical Officer
email None
of the documents provided 4 working days of Center
3.2 Finalizes decision on the LTO
application

If application is approved, the

None
FDA shall send the LTO to the 3 working days Center Director
registered email address of the
applicant.

56
 If application is disapproved,
the FDA shall inform the
applicant through its registered
email address of the reason for
such action on the application.
4. Receives notification and prints LTO if Qualified Person
application is approved
TOTAL: 7 working days

57
1.7.LICENSE TO OPERATE – INITIAL APPLICATION FOR FOOD MANUFACTURERS

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Drug Products
Fees to be Paid : Food Manufacturer:
250K and below- Php 1,000 + 1% LRF
Over 250K but not more than 500K- Php 1,500 + 1% LRF
Over 500K but not more than 1 Million- Php 2,000 + 1% LRF
Over 1 Million but below 5 Million – Php 4,000 + 1% LRF
5 Million but below 10 Million - Php 6,000 + 1% LRF
10 Million but below 20 Million – Php 10,000 + 1% LRF
20 Million but below 50 Million – Php 20,000 + 1% LRF
50 Million and above - Php 30,000 + 1% LRF
Iodized Salt Manufacturer:
Large Manufacturer (exceeding 2,000 m.t/year)- Php 2,000 + 1% LRF
Medium Manufacturer (>300 m.t to 2000 m.t/year)- Php 1000 + 1% LRF
Small Manufacturer (>200 m.t to 300 m.t/year- Php 400 + 1% LRF
Bottled Water Processor: Php 3,000 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

58
 CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1) Basic Requirements based on the Administrative Order No. 2020-0017:
Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal System
● Location plan and Global Positioning System (GPS) coordinates to be filled in the eApplication Form
● Name of the Qualified Person depending on the type of health product establishment
● Self-Declaration in the e-Application Form
2) Proof of Business Registration
Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade
and Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the
Securities and Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles of
Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with original
charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC)
and Articles of Incorporation, if without original charter (1 Scanned copy PDF)

When a business or establishment address is different from the business name registration address,
the applicant shall submit a copy of the Business Permit (e.g., Mayor’s Permit).
3) Proof of income (Latest Audited Financial Statement with Balance Sheet) or Duly notarized
Statement/Certification of Initial Capitalization.
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

5) Site Master File (shall be presented to the FDA inspectors during inspection)
6) Risk Management Plan (shall be presented to the FDA inspectors during inspection)

59
7) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be presented to
the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal for FDA Cashier
using the issued username and password, and confirmed payments. This will Administrative
uploads the required documentary requirements prompt automatic decking of and Finance
(in PDF format) for e-LTO application application to respective RFO. Service

Downloads and prints the generated Order of See above

LBP OnColl Payment : 5 wd
Payment through the ePortal System and email table
Other Payment Channels: 2
notification.
wd
Pays the assessed fee as per the system-
generated Order of Payment through the
existing payment channels
1.2 Conducts pre-licensing Regional Field
inspection Officer/ Inspector

Refer to Regional Field Office

(RFO) Citizen’s Charter for the None
issuance of Certificate of
Compliance /Recommendation
for Disapproval/
Recommendation Letter.

60
 1.3 Evaluates completeness and FDA Evaluator
veracity of the documents None 13 working days (Center/Licensing
submitted. and Registration)
1.4 Checks evaluation and veracity 3 working Technical Officer
of documents submitted. None of Center
days
1.5 Quality assurance of the Technical Officer
evaluation. None 1 working day of Center

1.6 Finalizes decision on the LTO Center Director

application
3 working days
If application is disapproved, the None
applicant will be notified through
email and will receive the Letter
of Denial
2. Receives notification and link of LTO for sprinting Qualified Person
TOTAL: 20 working
days

61
1.8.LICENSE TO OPERATE – RENEWAL APPLICATION FOR FOOD MANUFACTURERS

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Food Products
Fees to be Paid : Food Manufacturer:
250K and below- Php 1,000 + 1% LRF
Over 250K but not more than 500K- Php 1,500 + 1% LRF
Over 500K but not more than 1 Million- Php 2,000 + 1% LRF
Over 1 Million but below 5 Million – Php 4,000 + 1% LRF
5 Million but below 10 Million - Php 6,000 + 1% LRF
10 Million but below 20 Million – Php 10,000 + 1% LRF
20 Million but below 50 Million – Php 20,000 + 1% LRF
50 Million and above - Php 30,000 + 1% LRF
Iodized Salt Manufacturer:
Large Manufacturer (exceeding 2,000 m.t/year)- Php 2,000 + 1% LRF
Medium Manufacturer (>300 m.t to 2000 m.t/year)- Php 1000 + 1% LRF
Small Manufacturer (>200 m.t to 300 m.t/year- Php 400 + 1% LRF
Bottled Water Processor: Php 3,000 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-004

Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License
of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3,
Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing
62
 Rules and Regulations, and Other Purposes

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1) Basic Requirements based on the Administrative Order No. 2020-0017:
● Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal (www.fda.gov.ph)
● Declaration and Undertaking
2) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

3) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal System 1. Posts payment in ePortal for See above FDA Cashier
(http://eportal.fda.gov.ph) using the issued confirmed payments. This will table Administrative
username and password, and uploads the required prompt automatic decking of and Finance
documentary requirements (in PDF) for e-LTO application to respective Service
application
Center/Office

Downloads and prints the generated Order of

LBP OnColl Payment: 5 wd
Payment through the ePortal and Email notification
Other Payment Channels: 2
wd
Pays the assessed fee as per the system- generated
Order of Payment through the existing payment
channels

63
1.2 Conducts inspection (if None Regional Field
necessary) Officer/ Inspector

Refer to Regional Field

Office Citizen’s Charter for
the issuance of Certificate of
Compliance/
Recommendation for
Disapproval/
Recommendation Letter
1.3 Evaluates completeness None 3 working days FDA Evaluator
and veracity of the (Center/Licensing
documents submitted and Registration
1.4 Checks evaluation and None 1 working day Technical Officer
veracity of documents of Center
submitted.
1.5 Quality assurance of the None 1 working day Technical Officer
evaluation. of Center

1.6 Finalizes decision on the None 2 working days Center Director

Approval of LTO

If application is
disapproved, the applicant
will be notified through email
and will receive the Letter of
Denial

64
2. Receives notification and link of LTO for printing None Qualified Person

TOTAL: 7
working days

65
1.9.LICENSE TO OPERATE – MAJOR VARIATION APPLICATION FOR FOOD ESTABLISHMENT (MANUFACTURERS)

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Food Manufacturers
Fees to be Paid : Major Variation: Php 500 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS (based on Administrative Order No. 2020-0017) WHERE TO SECURE

Major Variation FDA ePortal System
(www.fda.gov.ph)
Transfer of Location of Manufacturing Plant
- Accomplished e-Application Form
- Business permit reflecting the new address
- Updated Site Master File to be presented upon inspection
- Payment of fees
Expansion of Manufacturer and/or Additional Product Line ; or Change of Manufacturing Activity
- Accomplished e-Application Form
- Updated Site Master File to be presented upon inspection

66
- Payment of fees

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal for FDA Cashier
using the issued username and password, and confirmed payments. This will Administrative
uploads the required documentary requirements (in prompt automatic decking of and Finance
PDF format) for e-LTO application application to respective RFO. Service

Downloads and prints the generated Order of See above

LBP OnColl Payment : 5 wd
Payment through the ePortal System and email table
Other Payment Channels : 2
notification.
wd
Pays the assessed fee as per the system-
generated Order of Payment through the existing
payment channels
1.2 Conducts inspection Regional Field
Officer/ Inspector
Refer to Regional Field Office (RFO)
Citizen’s Charter for the issuance of None
Certificate of Compliance
/Recommendation for Disapproval/
Recommendation Letter.
1.3 Evaluates completeness and FDA Evaluator
veracity of the documents None 13 working days (Center/Licensing
submitted. and Registration)

67
 1.4 Checks evaluation and veracity 3 working Technical Officer
of documents submitted. None of Center
days
1.5 Quality assurance of the Technical Officer
evaluation. None 1 working day of Center

1.6 Finalizes decision on the LTO Center Director

application
3 working days
If application is disapproved, the None
applicant will be notified through
email and will receive the Letter of
Denial
2. Receives notification and link of LTO for printing Qualified Person
TOTAL: 20 working
days

68
1.10.LICENSE TO OPERATE – INITIAL APPLICATION FOR FOOD TRADERS AND DISTRIBUTORS (IMPORTER, EXPORTER,
WHOLESALER)

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Food Traders and Food Distributors (Importer, Exporter, Wholesaler)
Fees to be Paid : Food Traders:
250K and below- Php 1,000 + 1% LRF
Over 250K but not more than 500K- Php 1,500 + 1% LRF
Over 500K but not more than 1 Million- Php 2,000 + 1% LRF
Over 1 Million but below 5 Million – Php 4,000 + 1% LRF
5 Million but below 10 Million - Php 6,000 + 1% LRF
10 Million but below 20 Million – Php 10,000 + 1% LRF
20 Million but below 50 Million – Php 20,000 + 1% LRF
50 Million and above - Php 30,000 + 1% LRF

Food Distributors:
Importer, Exporter, Wholesaler – Php 8,000 + 1% LRF
Iodized Salt Importer – Php 1,000 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

69
 CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1)Basic Requirements based on the Administrative Order No. 2020-0017:
Accomplished e-Application Form as prescribed by FDA regulations. . FDA eServices
● Location plan and Global Positioning System (GPS) coordinates to be filled in the e-Application Form (www.fda.gov.ph)
● Name of the Qualified Person depending on the type of health product establishment Self-Declaration in
the e-Application Form

2) Proof of Business Registration

Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade and
Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the
Securities and
Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles of
Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with original
charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC) and
Articles of Incorporation, if without original charter (1 Scanned copy PDF)

When a business or establishment address is different from the business name registration address, the
applicant shall submit a copy of the Business Permit (e.g. Mayor’s Permit).
3) Proof of income (for Trader) - Latest Audited Financial Statement with Balance Sheet or Duly notarized
Statement/Certification of Initial Capitalization.
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

5) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be presented to the
FDA inspectors during inspection

70
 CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON
BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1. Conducts pre-assessment on FDA Evaluator
http://eservices.fda.gov.ph and click the submitted application and (Center/Licensing
“Applications “found on the upper right corner of documentary requirements with and Registration)
the system.
regards to completeness and
Selects the product category (Food) and the type correctness.
of business establishment (Food Trader, Food
Distributor) before clicking “Initial” Application If the application passed the pre-
assessment step, the applicant
Reads the “Declaration and Undertaking
“before proceeding with the application process. shall receive the Order of
Check the box “I agree to the Declaration and Payment with Reference Number None
Undertaking” and click on “Start Application”. via email.

Fills-out all necessary information. All fields mark If not, the FDA shall notify the
with asterisk (*) are required to be filled-out.
client the reason/s for non-
Uploads the required documents as indicated on acceptance and prompt the
the Checklist of Requirements in pdf format. applicant to apply again through
the eServices Portal.
Reviews the duly filled out form in the Self-
Assessment Review. Once reviewed, click on
“Confirm” to submit the application.
2. Prints the Order of Payment form with Reference 2. Posts payment in eServices FDA Cashier
Number sent through the declared e-mail address Portal System for confirmed Administrative
payments. This will prompt See above and Finance
Pays the application fee through existing payment
channels automatic decking of application table Service (AFS)
to respective Center.

71
 LBP OnColl Payment: 5 wd
Other Payment Channels: 2 wd

Note: Acknowledgement Receipt

will automatically be sent to the
client once payment is posted and
will signify the start of processing
time of the application.
1. Receives Acknowledgement Receipt through 3.1 Checks and quality assurance Technical Officer
email of the documents provided None 11 working days of Center

3.2 Finalizes decision on the LTO Center Director

application

If application is approved, the

FDA shall send the LTO to the 3 working days
registered email address of the
applicant. None

If application is disapproved, the

FDA shall inform the applicant
through its registered email
address of the reason for such
action on the application.
2. Receives notification and prints LTO if Qualified Person
application is approved
TOTAL: 14
working days

72
1.11.LICENSE TO OPERATE – RENEWAL APPLICATION FOR FOOD TRADERS AND FOOD DISTRIBUTORS (IMPORTER, EXPORTER,
WHOLESALER)

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : All Food Traders and Food Distributors (Importer, Exporter, Wholesaler)
Fees to be Paid : Food Traders:
250K and below- Php 1,000 + 1% LRF
Over 250K but not more than 500K- Php 1,500 + 1% LRF
Over 500K but not more than 1 Million- Php 2,000 + 1% LRF
Over 1 Million but below 5 Million – Php 4,000 + 1% LRF
5 Million but below 10 Million - Php 6,000 + 1% LRF
10 Million but below 20 Million – Php 10,000 + 1% LRF
20 Million but below 50 Million – Php 20,000 + 1% LRF
50 Million and above - Php 30,000 + 1% LRF

Food Distributors:
Importer, Exporter, Wholesaler – Php 8,000 + 1% LRF
Iodized Salt Importer – Php 1,000 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-004

73
 Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License
of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3,
Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing
Rules and Regulations, and Other Purposes

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1) Basic Requirements based on the Administrative Order No. 2020-0017: FDA Website (www.fda.gov.ph)
● Accomplished e-Application Form as prescribed by FDA regulations.
● Declaration and Undertaking
2) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

3) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1. Posts confirmed payments. None FDA Cashier
https://eservices.fda.gov.ph and click This will prompt automatic Administrative
“Applications” found on the upper right corner of routing of application to Center and Finance
the system. Service
LBP OnColl Payment: 5 wd
Selects the product category (Drug) and the type of LBP Linkbiz: auto posting
business establishment (Drug Trader, Drug
Other Payment Channels: 2 wd
Distributor, Drugstore, RONPD, CRO, Sponsor)
before clicking “Renewal” application

74
Reads the “Declaration and Undertaking” before Note: Acknowledgement Receipt
proceeding with the application process. Check the will automatically be sent to
box “I agree to the Declaration and Undertaking” the client once payment is
and click on “Start Application”. posted and will signify the
start of processing time of the
Fills-out all necessary information. All fields mark application.
with asterisk (8*) are required to be filled-out.

Updates contact numbers if necessary. Click

“Next” to proceed to Self – Assessment Review

Reviews all details in the “Self-Assessment

Review”. Once reviewed, click on “Confirm” to
submit application.

Prints the Order of Payment with Reference Number

sent through the declared email address

Pays the application fee through existing payment

channels
2. Receives Acknowledgement Receipt through
email
3. Receives notification and link of LTO for None
Printing
TOTAL: The LTO shall be automatically generated by the system once the payment has
been posted by the FDA Cashier

75
1.12.LICENSE TO OPERATE – MINOR VARIATION APPLICATION FOR FOOD TRADERS AND FOOD DISTRIBUTORS (IMPORTER,
EXPORTER, WHOLESALER)

Center/Office/Division : Center for Food Regulation and Research (CFRR)

Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Food Traders and Food Distributors (Importer, Exporter, Wholesaler)
Fees to be Paid : Minor Variation: Php 500 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS (based on Administrative Order No. 2020-0017) WHERE TO SECURE

Minor Variation FDA eServices

(www.fda.gov.ph)
Transfer of Location of Offices
- Accomplished e-Application Form
- Business permit reflecting new location of office
- Payment of fees
Change of Distributor Activity
- Accomplished e-Application Form

76
- Contract Agreements showing change in activity
- Payment of fees
Transfer/Addition of Warehouse
- Accomplished e-Application Form
- Business Permit reflecting new warehouse location
- Payment of fees
Expansion of Office Establishments and Drug Retailers
- Accomplished e-Application Form
- Expansion floor plan
- Payment of fees
Change of Ownership
- Accomplished e-Application Form
- Business name registration reflecting new ownership
- Any proof on the transfer of ownership such as any of the following
 Deed of Sale or assignment or transfer of rights/ownership
 Memorandum of Agreement
 Notarized Affidavit of the owner, proprietor, Chairman or CEO of the establishment validating the
transfer
- Payment of fees
Change of Business Name
- Accomplished e-Application Form
- Business permit reflecting the new name
- Payment of fees
Zonal Change in Address
- Accomplished e-application Form
- Certificate of Zonal Change
- Payment of fees

77
Change of Qualified Person
- Accomplished e-Application Form
- Name of new qualified person
- Applicable requirements as specified in ANNEX B of AO 2020-0017
- Payment of fees
Change of Authorized Person
- Accomplished e-Application Form
- Name of new authorized person
- Updated contact details
- Payment of fees

CLIENT STEPS AGENCY ACTION FEES PROCESSING PERSON

TO BE TIME RESPONSIBLE
PAID
1. Access the online application portal through 1. Conducts pre-assessment on the FDA Evaluator
http://eservices.fda.gov.ph and click submitted application and (Center/Licensing
“Applications “found on the upper right corner of and Registration)
documentary requirements with
the system.
regards to completeness and
Selects the product category (Food) and the type of correctness.
business establishment (Food Trader, Food
Distributor) before clicking “Variations” If the application passed the pre- None
assessment step, the applicant
Reads the “Declaration and Undertaking “before
shall receive the Order of Payment
proceeding with the application process. Check
the box “I agree to the Declaration and with Reference Number via email.
Undertaking” and click on “Start Application”.
If not, the FDA shall notify the client
Fills-out all necessary information. All fields mark the reason/s for non-acceptance and
with asterisk (*) are required to be filled-out.
78
 prompt the applicant to apply again
Uploads the required documents as indicated on the through the eServices Portal.
Checklist of Requirements in pdf format.

Reviews the duly filled out form in the Self-

Assessment Review. Once reviewed, click on
“Confirm” to submit the application.
2. Prints the Order of Payment form with Reference 2. Posts payment in eServices Portal FDA Cashier
Number sent through the declared e-mail address System for confirmed payments. Administrative
This will prompt automatic and Finance
Pays the application fee through existing payment
channels decking of application to Service (AFS)
respective Center.

LBP OnColl Payment: 5 wd See

Other Payment Channels: above
2 wd table

Note: Acknowledgement Receipt will

automatically be sent to the client
once payment is posted and will
signify the start of processing time of
the application.
3. Receives Acknowledgement Receipt through 3.1 Checks and quality assurance of Technical Officer
email the documents provided None 4 working days of Center

79
 3.2 Finalizes decision on the LTO
application

If application is approved, the FDA

shall send the LTO to the registered 3 working days Center Director
email address of the applicant.
None

If application is disapproved, the

FDA shall inform the applicant
through its registered email
address of the reason for such
action on the application.
4. Receives notification and prints LTO if application Qualified Person
is approved
TOTAL: 7 working days

80
1.13.LICENSE TO OPERATE – INITIAL APPLICATION FOR MEDICAL DEVICE MANUFACTURERS

Center/Office/Division : Center for Device Regulation, Radiation and Health Research (CDRRHR)
Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Medical Device Products
Fees to be Paid : Medical Device Manufacturer:
20 Million and below – Php 5,000 +1% LRF
over 20 Million but below 50 Million – Php 7,000 +1% LRF
50 Million and above – Php 10,000 +1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1) Basic Requirements based on the Administrative Order No. 2020-0017:
Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal System
● Location plan and Global Positioning System (GPS) coordinates to be filled in the eApplication Form
● Name of the Qualified Person depending on the type of health product establishment
● Self-Declaration in the e-Application Form

81
2) Proof of Business Registration
Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade
and Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the
Securities and Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles of
Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with original
charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC)
and Articles of Incorporation, if without original charter (1 Scanned copy PDF)

When a business or establishment address is different from the business name registration address,
the applicant shall submit a copy of the Business Permit (e.g., Mayor’s Permit).
3) Proof of income (Latest Audited Financial Statement with Balance Sheet) or Duly notarized
Statement/Certification of Initial Capitalization.
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

5) Site Master File (shall be presented to the FDA inspectors during inspection)
6) Risk Management Plan (shall be presented to the FDA inspectors during inspection)
7) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be presented to
the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal for See above FDA Cashier
using the issued username and password, and confirmed payments. This will table
82
 uploads the required documentary requirements prompt automatic decking of Administrative
(in PDF format) for e-LTO application application to respective RFO. and Finance
Service
Downloads and prints the generated Order of LBP OnColl Payment: 5 wd
Payment through the ePortal System and email Other Payment Channels: 2
notification. wd

Pays the assessed fee as per the system-

generated Order of Payment through the
existing payment channels
1.2 Conducts pre-licensing Regional Field
inspection Officer/ Inspector

Refer to Regional Field Office

(RFO) Citizen’s Charter for the None
issuance of Certificate of
Compliance /Recommendation
for Disapproval/
Recommendation Letter.
1.3 Evaluates completeness and FDA Evaluator
veracity of the documents None 13 working days (Center/Licensing
submitted. and Registration)
1.4 Checks evaluation and veracity 3 working Technical Officer
of documents submitted. None of Center
days
1.5 Quality assurance of the Technical Officer
evaluation. None 1 working day of Center

83
 1.6 Finalizes decision on the LTO Center Director
application
3 working days
If application is disapproved, the None
applicant will be notified through
email and will receive the Letter
of Denial
2. Receives notification and link of LTO for printing Qualified Person
TOTAL: 20 working
days

84
1.14.LICENSE TO OPERATE – RENEWAL APPLICATION FOR MEDICAL DEVICE MANUFACTURERS

Center/Office/Division : Center for Device Regulation, Radiation and Health Research (CDRRHR)
Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Medical Device Products
Fees to be Paid : Medical Device Manufacturer:
20 Million and below – Php 5,000 +1% LRF
over 20 Million but below 50 Million – Php 7,000 +1% LRF
50 Million and above – Php 10,000 +1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-004

Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License
of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3,
Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing
Rules and Regulations, and Other Purposes

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1) Basic Requirements based on the Administrative Order No. 2020-0017:
● Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal (www.fda.gov.ph)
● Declaration and Undertaking

85
2) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

3) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal System 1.1 Posts payment in ePortal for See above FDA Cashier
(http://eportal.fda.gov.ph) using the issued confirmed payments. This will table Administrative
username and password, and uploads the prompt automatic decking of and Finance
required documentary requirements (in PDF) for application to respective Service
e-LTO application
Center/Office

Downloads and prints the generated Order of

LBP OnColl Payment: 5 wd
Payment through the ePortal and Email
notification Other Payment Channels:
1. 2 wd
Pays the assessed fee as per the system- generated
Order of Payment through the existing payment
channels
1.2 Conducts inspection (if None Regional Field
necessary) Officer/ Inspector

Refer to Regional Field Office

Citizen’s Charter for the issuance
of Certificate of Compliance/

86
 Recommendation for
Disapproval/ Recommendation
Letter
1.3 Evaluates completeness and None 3 working days FDA Evaluator
veracity of the documents (Center/Licensing
submitted and Registration
1.4 Checks evaluation and None 1 working day Technical Officer
veracity of documents of Center
submitted.
1.5 Quality assurance of the None 1 working day Technical Officer
evaluation. of Center

1.6 Finalizes decision on the None 2 working days Center Director

Approval of LTO

If application is disapproved,
the applicant will be notified
through email and will receive
the Letter of Denial
2. Receives notification and link of LTO for printing None Qualified Person

TOTAL: 7
working days

87
1.15..LICENSE TO OPERATE – MAJOR VARIATION APPLICATION FOR MEDICAL DEVICE ESTABLISHMENT (MANUFACTURERS)

Center/Office/Division : Center for Device Regulation, Radiation, and Health Research (CDRRHR)
Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Medical Device Manufacturers
Fees to be Paid : Major Variation: Php 500 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS (based on Administrative Order No. 2020-0017) WHERE TO SECURE

Major Variation FDA ePortal System
(www.fda.gov.ph)
Transfer of Location of Manufacturing Plant
- Accomplished e-Application Form
- Business permit reflecting the new address
- Updated Site Master File to be presented upon inspection
- Payment of fees
Expansion of Manufacturer and/or Additional Product Line; or Change of Manufacturing Activity
- Accomplished e-Application Form
- Updated Site Master File to be presented upon inspection

88
- Payment of fees

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal for Qualified Person
using the issued username and password, and confirmed payments. This will
uploads the required documentary requirements (in prompt automatic decking of FDA Cashier
PDF format) for e-LTO application application to respective RFO. Administrative
and Finance
Downloads and prints the generated Order of See above
LBP OnColl Payment: 5 wd Service
Payment through the ePortal System and email table
Other Payment Channels: 2
notification.
wd
Pays the assessed fee as per the system-
generated Order of Payment through the existing
payment channels
1.2 Conducts inspection Regional Field
Officer/ Inspector
Refer to Regional Field Office
(RFO) Citizen’s Charter for the
None
issuance of Certificate of
Compliance /Recommendation
for Disapproval/
Recommendation Letter.

89
 1.3 Evaluates completeness and FDA Evaluator
veracity of the documents None 13 working days (Center/Licensing
submitted. and Registration)
Checks evaluation and veracity Technical Officer
of documents submitted. 3 working of Center
None
days

1.4 Quality assurance of the Technical Officer of

None 1 working day Center
evaluation.
1.5 Finalizes decision on the LTO Center Director
application
3 working days
1.6 If application is disapproved, None
the applicant will be notified
through email and will receive
the Letter of Denial
2. Receives notification and link of LTO for printing Qualified Person
TOTAL: 20 working
days

90
1.16.LICENSE TO OPERATE – INITIAL APPLICATION FOR MEDICAL DEVICE TRADERS AND DISTRIBUTORS (IMPORTER, EXPORTER,
WHOLESALER)

Center/Office/Division : Center for Device Regulation, Radiation and Health Research (CDRRHR)
Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Medical Device Traders and Distributors (Importer, Exporter, Wholesaler)

Fees to be Paid : Medical Device Trader:

20 million and below – Php 3,000 + 1% LRF
Over 20 million but below 50 million – Php 5,000 + 1% LRF
50 million and above – Php 7,000 + 1% LRF

Medical Device Distributors (Importer, Exporter, Wholesaler) :

Php 4,000 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1)Basic Requirements based on the Administrative Order No. 2020-0017: FDA website
(www.fda.gov.ph)
91
Accomplished e-Application Form as prescribed by FDA regulations. FDA eServices
● Location plan and Global Positioning System (GPS) coordinates to be filled in the e-Application Form (www.fda.gov.ph)
● Name of the Qualified Person depending on the type of health product establishment Self-Declaration in
the e-Application Form

2) Proof of Business Registration

Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade and
Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the
Securities and
Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles of
Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with original
charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC) and
Articles of Incorporation, if without original charter (1 Scanned copy PDF)

When a business or establishment address is different from the business name registration address, the
applicant shall submit a copy of the Business Permit (e.g., Mayor’s Permit).
3) Proof of income (for Trader) - Latest Audited Financial Statement with Balance Sheet or Duly notarized
Statement/Certification of Initial Capitalization.
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

5) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be presented to the
FDA inspectors during inspection

92
 CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON
BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1.1 Conducts pre-assessment on FDA Evaluator
http://eservices.fda.gov.ph and click the submitted application and (Center/Licensing
“Applications“ found on the upper right corner of documentary requirements with and Registration)
the system.
regards to completeness and
Selects the product category (Medical Device) and correctness.
the type of business establishment (Medical
Device Trader, Medical Device Distributor) before If the application passed the pre-
clicking “Initial” Application assessment step, the applicant
Reads the “Declaration and Undertaking shall receive the Order of
“before proceeding with the application process. Payment with Reference Number
Check the box “I agree to the Declaration and via email.
Undertaking” and click on “Start Application”.
If not, the FDA shall notify the None
Fills-out all necessary information. All fields mark
client the reason/s for non-
with asterisk (*) are required to be filled-out.
acceptance and prompt the
Uploads the required documents as indicated on applicant to apply again through
the Checklist of Requirements in pdf format. the eServices Portal.

Reviews the duly filled out form in the Self-

Assessment Review. Once reviewed, click on
“Confirm” to submit the application.

Prints the Order of Payment form with Reference

Number sent through the declared e-mail address

93
2. Pays the application fee through existing payment 2.1 Posts payment in eServices 0 Qualified Person
channels Portal System for confirmed
payments. This will prompt FDA Cashier
Receives Acknowledgement Receipt through automatic decking of application Administrative
email to respective Center. and Finance
Service (AFS)
LBP OnColl Payment: 5 wd
See above
Other Payment Channels: 2
table
wd

Note: Acknowledgement Receipt

will automatically be sent to the
client once payment is posted and
will signify the start of processing
time of the application.
2.2 Checks and quality assurance Technical Officer
of the documents provided None 11 working days of Center

2.3 Finalizes decision on the LTO Center Director

application

If application is approved, the

FDA shall send the LTO to the 3 working days
None
registered email address of the
applicant.

If application is disapproved,
the FDA shall inform the
94
 applicant through its registered
email address of the reason for
such action on the application.

3. Receives notification and prints LTO if application Qualified Person

is approved
TOTAL: 14
working days

95
1.17.LICENSE TO OPERATE – RENEWAL APPLICATION FOR MEDICAL DEVICE TRADERS AND MEDICAL DEVICE DISTRIBUTORS
(IMPORTER, EXPORTER, WHOLESALER)

Center/Office/Division : Center for Device Regulation, Radiation and Health Research (CDRRHR)
Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : All Medical Device Traders and Medical Device Distributors (Importer, Exporter, Wholesaler)
Fees to be Paid : Medical Device Trader :
20 million and below – Php 3,000 + 1% LRF
Over 20 million but below 50 million – Php 5,000 + 1% LRF
50 million and above – Php 7,000 + 1% LRF

Medical Device Distributors (Importer, Exporter, Wholesaler) :

Php 4,000 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food
and Drugs

FDA Circular No. 2011-004

Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering
License of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section
3, Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing
Rules and Regulations, and Other Purposes

FDA Circular No. 2011-003

Collection of Legal Research Fee (LRF) Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
96
 CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1) Basic Requirements based on the Administrative Order No. 2020-0017: FDA Website (www.fda.gov.ph)
● Accomplished e-Application Form as prescribed by FDA regulations.
● Declaration and Undertaking
2) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

3) Refer to FROO Inspection Agenda of this Citizen’s Charter for the documents that will be
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1. System sends the Order of None 0 Qualified Person
https://eservices.fda.gov.ph and click Payment after receipt of the
“Applications” found on the upper right corner of application
the system.

Selects the product category (Drug) and the type of

business establishment (Drug Trader, Drug
Distributor, Drugstore, RONPD, CRO, Sponsor)
before clicking “Renewal” application

Reads the “Declaration and Undertaking” before

proceeding with the application process. Check the
box “I agree to the Declaration and Undertaking” and
click on “Start Application”.

Fills-out all necessary information. All fields mark

with asterisk (8*) are required to be filled-out.

97
Updates contact numbers if necessary. Click “Next”
to proceed to Self – Assessment Review

Reviews all details in the “Self-Assessment

Review”. Once reviewed, click on “Confirm” to
submit application.

Prints the Order of Payment with Reference Number

sent through the declared email address
2. Pays the application fee through existing payment 2. Posts confirmed payments. None FDA Cashier
channels This will prompt automatic Administrative
routing of application to and Finance
Receives Acknowledgement Receipt through email Center Service

LBP OnColl Payment:

5 wd
LBP Linkbiz: auto posting
Other Payment Channels:
2 wd

Note: Acknowledgement
Receipt will automatically
be sent to the client once
payment is posted and will
signify the start of
processing time of the
application.

98
1.6.1.1 Receives notification and link of LTO None
for
Printing
TOTAL: The LTO shall be automatically generated by the system once the payment has
been posted by the FDA Cashier

99
1.18.LICENSE TO OPERATE – MINOR VARIATION APPLICATION FOR MEDICAL DEVICE TRADERS AND MEDICAL DEVICE
DISTRIBUTORS (IMPORTER, EXPORTER, WHOLESALER)

Center/Office/Division : Center for Device Regulation, Radiation, and Health Research (CDRRHR)
Classification : Complex
Type of Transaction : G2B – Government to Business
Who May Avail : All Medical Device Traders and Medical Device Distributors (Importer, Exporter, Wholesaler)
Fees to be Paid : Minor Variation: Php 500 + 1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS (based on Administrative Order No. 2020-0017) WHERE TO SECURE

Minor Variation FDA eServices

(www.fda.gov.ph)
Transfer of Location of Offices
- Accomplished e-Application Form
- Business permit reflecting new location of office
- Payment of fees
Change of Distributor Activity

100
- Accomplished e-Application Form
- Contract Agreements showing change in activity
- Payment of fees
Transfer/Addition of Warehouse
- Accomplished e-Application Form
- Business Permit reflecting new warehouse location
- Payment of fees
Expansion of Office Establishments and Drug Retailers
- Accomplished e-Application Form
- Expansion floor plan
- Payment of fees
Change of Ownership
- Accomplished e-Application Form
- Business name registration reflecting new ownership
- Any proof on the transfer of ownership such as any of the following
 Deed of Sale or assignment or transfer of rights/ownership
 Memorandum of Agreement
 Notarized Affidavit of the owner, proprietor, Chairman or CEO of the establishment validating the
transfer
- Payment of fees
Change of Business Name
- Accomplished e-Application Form
- Business permit reflecting the new name
- Payment of fees
Zonal Change in Address
- Accomplished e-application Form
- Certificate of Zonal Change

101
- Payment of fees

Change of Qualified Person

- Accomplished e-Application Form
- Name of new qualified person
- Applicable requirements as specified in ANNEX B of AO 2020-0017
- Payment of fees
Change of Authorized Person
- Accomplished e-Application Form
- Name of new authorized person
- Updated contact details
- Payment of fees

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1. Conducts pre-assessment on FDA Evaluator
http://eservices.fda.gov.ph and click the submitted application and (Center/Licensing
“Applications” found on the upper right corner and Registration)
documentary requirements
of the system.
with regards to completeness
Selects the product category (Food) and the type of and correctness.
business establishment (Food Trader, Food
Distributor) before clicking “Variations” None
If the application passed the
pre-assessment step, the
Reads the “Declaration and Undertaking” before
applicant shall receive the
proceeding with the application process. Check
the box “I agree to the Declaration and Order of Payment with
Undertaking” and click on “Start Application”. Reference Number via email.

102
Fills-out all necessary information. All fields mark If not, the FDA shall notify the
with asterisk (*) are required to be filled-out. client the reason/s for non-
acceptance and prompt the
Uploads the required documents as indicated on the
Checklist of Requirements in pdf format. applicant to apply again
through the eServices Portal.
Reviews the duly filled out form in the Self-
Assessment Review. Once reviewed, click on
“Confirm” to submit the application.

Prints the Order of Payment form with Reference

Number sent through the declared e-mail address
2. Pays the application fee through existing payment 2.1 Posts payment in 0 FDA Cashier
channels eServices Portal System for Administrative and
confirmed payments. This will Finance Service
Receives Acknowledgement Receipt through email
prompt automatic decking of (AFS)
application to respective
Center.

LBP OnColl Payment: See above

5 wd table
Other Payment Channels:
2 wd

Note: Acknowledgement
Receipt will automatically be
sent to the client once
payment is posted and will

103
 signify the start of processing
time of the application.

2.2 Checks and quality Technical Officer

assurance of the documents None 4 working days of Center
provided
2.3 Finalizes decision on the
LTO application 3 working days

If application is approved, the

FDA shall send the LTO to the Center Director
registered email address of the
None
applicant.
If application is disapproved,
the FDA shall inform the
applicant through its registered
email address of the reason for
such action on the application.
3. Receives notification and prints LTO if Qualified Person
application is approved
TOTAL: 7 working days

104
1.19. LICENSE TO OPERATE – INITIAL APPLICATION FOR MANUFACTURERS OF COSMETICS, TOYS AND CHILD CARE ARTICLES
(TCCAS) AND HOUSEHOLD URBAN PESTICIDES (HUPS)

Center/Office/Division : Center for Cosmetic and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : Manufacturers of Cosmetics, Toys and Child Care Articles and Household Urban Pesticides
Fees to be Paid : Cosmetics Manufacturer:
20 Million and below - Php 5,000 +1 % LRF
over 20 Million but below 50 Million - Php 10,000 + 1 % LRF
50 Million and above - Php 15,000 + 1 % LRF

Household Hazardous Substance Manufacturer:

1 Million and below - Php 1,000 + 1 % LRF
over 1 Million but below 5 Million - Php 2,000 + 1 % LRF
5 Million but below 10 Million - Php 3,000 + 1 % LRF
10 Million but below 20 Million - Php 5,000 + 1 % LRF`
20 Million but below 50 Million - Php 10,000 + 1 % LRF
50 Million and above - Php 15,000 + 1 % LRF

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food
and Drugs

FDA Circular No. 2011-003

105
 Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1) Basic Requirements based on the Administrative Order No. 2020-0017:
Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal System
● Location plan and Global Positioning System (GPS) coordinates to be filled in the eApplication Form (www.fda.gov.ph)
● Name of the Qualified Person depending on the type of health product establishment
● Self-Declaration in the e-Application Form
2) Proof of Business Registration
Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade
and Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the
Securities and
Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles of
Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with original
charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC)
and Articles of Incorporation, if without original charter (1 Scanned copy PDF)

When a business or establishment address is different from the business name registration address,
the applicant shall submit a copy of the Business Permit (e.g. Mayor’s Permit).
3) Proof of income (Latest Audited Financial Statement with Balance Sheet) or Duly notarized
Statement/Certification of Initial Capitalization.

106
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).
5) Site Master File (shall be presented to the FDA inspectors during inspection)
6) Risk Management Plan (shall be presented to the FDA inspectors during inspection)
7) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be presented to
the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION1 FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal for Qualified Person
using the issued username and password, and confirmed payments. This will
uploads the required documentary requirements prompt automatic decking of FDA Cashier
(in PDF format) for e-LTO application application to respective RFO. Administrative
and Finance
Downloads and prints the generated Order of See above
LBP OnColl Payment: 5 wd 0 Service
Payment through the ePortal and Email table
Other Payment Channels: 3
notification.
wd
Pays the assessed fee as per the system-
generated Order of Payment Form through the
existing payment channels
1.2 Conducts pre-licensing Regional Field
inspection. Officer/Inspector

Refer to Regional Field Office None 0

Citizen’s Charter for the issuance
of Certificate of
Compliance/Recommendation for

107
 Disapproval/ Recommendation
Letter.
1.3 Evaluates completeness and FDA Evaluator
veracity of the documents (Center/Licensing
submitted. and Registration)
13
None
working days

1.4 Checks evaluation and veracity Technical Office

None 3 working days
of the documents submitted. of Center
1.5 Quality assurance of the Technical Officer
evaluation. None 1 working day of Center

1.6 Finalizes decision on the

application.
Center Director
3
If application is disapproved, the None
working days
applicant will be notified through
email ad will receive the Letter of
Denial
2. Receives notification and link of LTO for printing Qualified Person
TOTAL: 20 working
days

108
1.20.LICENSE TO OPERATE – RENEWAL APPLICATION FOR MANUFACTURERS OF COSMETICS, TOYS AND CHILD CARE ARTICLES
(TCCAS) AND HOUSEHOLD URBAN PESTICIDES (HUPS)

Center/Office/Division : Center for Cosmetic and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR)
Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : Manufacturers of Cosmetics, Toys and Childcare Articles and Household Urban Pesticides
Fees to be Paid : Cosmetics Manufacturer:
20 Million and below - Php 10,000 + 1 % LRF
over 20 Million but below 50 Million - Php 20,000 + 1 % LRF
50 Million and above - Php 15,000 + 1 % LRF

Household Hazardous Substance Manufacturer:

1 Million and below - Php 2,000 + 10 % LRF
over 1 Million but below 5 Million - Php 4,000 + 1 % LRF
5 Million but below 10 Million - Php 6,000 + 1 % LRF
10 Million but below 20 Million - Php 10,000 + 1 % LRF
20 Million but below 50 Million - Php 20,000 + 1% LRF
50 Million and above - Php 30,000 + 1% LRF

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-004

Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License
of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3,
Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing
109
 Rules and Regulations, and Other Purposes

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1)Basic Requirements based on the Administrative Order No. 2020-0017:
● Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal (www.fda.gov.ph)
● Declaration and Undertaking Applicant /Qualified Person
2) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001). FDA Cashier/Other FDA Authorized
Payment Portals or Banks
3) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be Applicant/Qualified person
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal See above 0 FDA Cashier
using the issued username and password, and for confirmed payments. This table Administrative
uploads the required documentary requirements will prompt automatic decking and Finance
(in PDF) for e-LTO application of application to respective Service
Center/Office.
Downloads and prints the generated Order of
Payment through the ePortal and Email notification

Pay the assessed fee as per the system generated

Order of Payment Form through the existing
payment channels

110
 1.2 Conducts inspection None Regional Field
Officer/ Inspector
Refer to Regional Field Office
Citizen’s Charter for the issuance
of Certificate of
Compliance/Recommendation for
Disapproval/ Recommendation
Letter
1.3 Evaluates completeness and None 3 working days FDA Evaluator
veracity of the documents (Center/Licensing
submitted and Registration)
1.4 Checks evaluation and veracity None 2 working day Technical Officer
of documents submitted. of Center

1.5 Quality assurance of the None 1 working day Technical Officer

evaluation. of Center

1.6 Finalizes decision on the None 1 working day Center Director

Approval of LTO

If application is disapproved, the

applicant will be notified through
email and will receive the Letter of
Denial
2. Receives notification and link of LTO for printing None Qualified Person

TOTAL: 7 working
days

111
1.21.LICENSE TO OPERATE – MAJOR VARIATION APPLICATION

Center/Office/Division : Center for Cosmetic and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : Manufacturers of Cosmetics, Toys and Childcare Articles, and Household Urban Pesticides
Fees to be Paid : Major Variation – Php 500 +1% LRF

Administrative Order 50 s. 2001

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

(Based on Administrative Order No. 2020-0017)
Major Variation
A. Transfer of Location of Manufacturing Plant Qualified Person
1. Accomplished e-Application Form
2. Business permit reflecting the new address
3. Updated Site Master File to be presented upon inspection
4. Payment of fees

112
B. Expansion of Manufacturer and/or Additional Product Line; or Change of Manufacturing
Activity
1. Accomplished e-Application Form
2. Updated Site Master File to be presented upon inspection
3. Payment of fees

1) Proof of payment of fees as prescribed by current FDA regulations (AO 50 s. 2001). FDA Cashier/Other FDA Authorized Payment
Portals or Banks
2) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be Applicant/Qualified person
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-Portal 1.1 Posts payment in ePortal for See above 0 FDA Cashier
(http://eportal.fda.gov.ph) using the confirmed payments. This will table Administrative
issued username and password, and prompt automatic decking of and Finance
uploads the required documentary application to respective RFO. Service
requirements for e-LTO application

Downloads and prints the generated Order of

LBP OnColl Payment: 5wd
Payment through the ePortal and Email
Other Payment Channels: 2 wd
notification

Pays the assessed fee as per the system-

generated Order of Payment Form through the
existing payment channels

113
 1.2 Conducts inspection None 0 Regional Field
Officer/
Refer to Regional Field Office Inspector
Citizen’s Charter for the issuance of
Certificate of
Compliance/Recommendation for
Disapproval/ Recommendation Letter
1.3 Evaluates completeness and None 12 working FDA Evaluator
veracity of the documents days (Center/Licensing
submitted. and Registration)
1.4 Checks evaluation and veracity of None 4 working days Technical Officer
documents submitted. of Center

1.4 Quality assurance of the None 2 working day Technical Officer

evaluation. of Center

1.5 Finalizes decision on the LTO None 2 working days Center Director
application

If the application is disapproved, the

applicant will be notified through
email and will receive the letter of
Denial
2. Receives notification and link of LTO for Qualified Person
printing
TOTAL: 20 working
days

114
1.22.LICENSE TO OPERATE – INITIAL APPLICATION FOR TRADERS, DISTRIBUTORS (IMPORTER, EXPORTER, WHOLESALER) OF
COSMETICS, TOYS AND CHILD CARE ARTICLES (TCCAS) AND HOUSEHOLD URBAN PESTICIDES (HUPS)

Center/Division : Center for Cosmetic and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B – Government to Business
Who May Avail : All Traders, Distributors (Importer, Exporter, Wholesaler) Cosmetics, Toys and Child Care Articles (TCCAs) and
Household Urban Pesticides (HUPs)
Fees to be Paid : Cosmetics Trader:
20 Million and below -Php 3,000+ 1 % LRF
over 20 Million but below 50 Million- Php 5,000+ 1% LRF
50 Million and above - Php 7,000+ 1 % LRF

Cosmetics Distributors:
Importer, Exporter, Wholesaler - Php 3,000+ 1 % LRF

Household Hazardous Substances:

Importer, Exporter, Wholesaler- Php 3,000+ 1 % LRF

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and
Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended
by PD 1856

115
 CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1)Basic Requirements based on the Administrative Order No. 2020-0017: FDA e-Portal (www.fda.gov.ph)
● Accomplished e-Application Form as prescribed by FDA regulations.
● Location plan and Global Positioning System (GPS) to be filled in the eApplication Form
● Name of the Qualified Person Self-Declaration in the e-Application Form
2) Proof of Business Registration
Any one of the following shall be submitted as proof of business name registration:
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade
and Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by
the Securities and Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy
PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles
of Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with
original charter, or its Certificate of Registration issued by the Securities and Exchange Commission
(SEC) and Articles of Incorporation, if without original charter include Mayor’s Permit or Barangay
Clearance provision (1 Scanned copy PDF)
A copy of Business permit (i.e., Mayor’s Permit or Barangay Clearance provision) will be submitted for
business or establishment address with different business name registration address.
3) Proof of income (Latest Audited Financial Statement with Balance Sheet) or Duly notarized
Statement/Certification of Initial Capitalization.
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).
5) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be presented
to the FDA inspectors during inspection

116
 CLIENT STEPS AGENCY ACTION FEES TO BE PROCESSING PERSON
PAID TIME RESPONSIBLE
1. Logs in to the e-Portal 1.1 Posts payment in ePortal for See above 0 FDA Cashier
(http://eportal.fda.gov.ph) using the confirmed payments. This will table Administrative
issued username and password, and prompt automatic decking of and Finance
uploads the required documentary application to respective Center. Service (AFS)
requirements for e-LTO application
LBP OnColl Payment : 5wd
Downloads and prints the generated Order Other Payment Channels : 3 wd
of Payment through the ePortal and
Email notification.

Pays the assessed fee as per the system-

generated Order of Payment Form
through the existing payment channels
1.2 Evaluates completeness and None 5 working days FDA Evaluator
correctness of the documents (Center/Licensing
submitted. and Registration
Division)
1.3 Checks the veracity of documents None 4 working days Technical Officer
provided of Center
1.4 Quality assurance of the documents None 3 working days Technical Officer
provided and compliance of Center

1.6 Finalizes decision on the LTO None 2 working days Center Director
application

117
 If application is disapproved, the
applicant will be notified through email
and will receive the Letter of Denial
3. Receives notification and link of LTO None Qualified Person
for printing
TOTAL: 14 working days

118
1.23.LICENSE TO OPERATE – RENEWAL APPLICATION LICENSE TO OPERATE FOR TRADERS, DISTRIBUTORS (IMPORTER,
EXPORTER, WHOLESALER) OF COSMETICS, TOYS AND CHILD CARE ARTICLES (TCCAS) AND HOUSEHOLD URBAN PESTICIDES
(HUPS)

Center/Office/Division : Center for Cosmetic and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B – Government to Business
Who May Avail : All Traders, Distributors (Importer, Exporter, Wholesaler) Cosmetics, Toys and Child Care Articles (TCCAs) and
Household Urban Pesticides (HUPs)
Fees to be Paid : Cosmetics Trader:
20 Million and below - Php 6,000 + 1 % LRF
over 20 Million but below 50 Million - Php 10,000 + 1 % LRF
50 Million and above - Php14,000 + 1 % LRF

Cosmetics Distributors:
Importer, Exporter, Wholesaler Php 6,000 + 1 % LRF

Household Hazardous Substances:

Importer, Exporter, Wholesaler - Php 6,000 + 1 % LRF

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food
and Drugs
FDA Circular No. 2011-003
Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
FDA Circular No. 2011-004

119
 Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering
License of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section
3, Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing Rules and Regulations, and
Other Purposes

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1) Basic Requirements based on the Administrative Order No. 2020-0017:

● Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal (www.fda.gov.ph)

● Declaration and Undertaking Applicant / Qualified Person
2) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001). FDA Cashier/Other FDA Authorized
Payment Portals or Banks
3) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be Applicant/Qualified person
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-portal (http://eportal.fda.gov.ph) 1.1 Posts payment in ePortal for See above FDA Cashier
using the issued username and password, and confirmed payments. This will table Administrative
uploads the required documentary requirements prompt automatic decking of and Finance
for e-LTO application application to respective Service (AFS)
Center/Office.
Downloads and prints the generated Order of
Payment through the ePortal and Email
notification

120
Pays the assessed fee as per the system-
generated Order of Payment Form through
1.2 Evaluates completeness and None 5 working days FDA Evaluator
correctness of documents (Center/Licensing
submitted. and Registration
Division)
1.3 Checks and quality assurance None 4 working days Technical Officer
of the documents provided and of Center
compliance
1.4 Quality assurance of the None 3 working days Technical Officer
evaluation of Center

1.5 Finalizes decision on LTO None 2 working days Center Director

application

If application is disapproved,
the applicant will be notified
through email and will receive
the Letter of Denial
2. Receives notification and link of LTO for printing Qualified person
TOTAL: 14 working days

121
1.24.LICENSE TO OPERATE – MINOR VARIATION APPLICATION FOR COSMETICS, TOYS AND CHILD CARE ARTICLES (TCCAS) AND
HOUSEHOLD URBAN PESTICIDES (HUPS)

Center/Office/Division : Center for Cosmetic and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : All Traders, Distributors (Importer, Exporter, Wholesaler of Cosmetics, Toys and Child Care Articles (TCCAs) and
Household Urban Pesticides (HUPs)
Fees to be Paid : Minor Variation: Php 500 +1% LRF

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food
and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
CHECKLIST OF REQUIREMENTS (based on Administrative Order No. 2020-0017) WHERE TO SECURE
Minor Variation FDA website (www.fda.gov.ph)
A. Transfer of Location Offices Qualified Person
- Accomplished e-Application Form
- Business permit reflecting new location of office
- Payment of fees

B. Change of Distributor Activity

- Accomplished e-Application Form
- Contract Agreements showing change in activity

122
 - Payment of fees

C. Transfer or Addition of Warehouse

- Accomplished e-Application Form
- Business Permit reflecting new warehouse location

- Payment of fees

D. Expansion of Office Establishment

- Accomplished e-Application Form
- Current floor plan and Expansion floor plan
- Payment of fees

E. Change of Ownership
- Accomplished e-Application Form
- Business name registration reflecting new ownership
- Any proof on the transfer of ownership
● Deed of sale or assignment or transfer of rights/ownership;
● Memorandum of Agreement; or
● Notarized Affidavit of the owner, proprietor, Chairman or CEO of the establishment validating the
transfer
- Payment of fees

F. Change of Business Name

- Accomplished e-Application Form
- Business permit reflecting the new name
- Payment of fees

G. Zonal Change in Address

123
 - Accomplished e-Application Form
- Certificate of Zonal Address
- Payment of Fees

H. Change of Qualified Person

- Accomplished e-Application Form
- Name of new qualified person, with credentials when applicable
- Applicable requirements as specified in ANNEX B of AO 2020-0017
- Payment of fees

I. Change of Authorized Person

- Accomplished e-Application Form
- Name of new authorized person
- Updated contact details
- Payment of fees

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Logs in to the e-portal 1.1 Posts payment in ePortal for See above FDA Cashier
(http://eportal.fda.gov.ph) using the issued confirmed payments. This will automatic table Administrative
username and password, and uploads the decking of application to respective and Finance
required documentary requirements for e-LTO Center. Service (AFS)
application

Downloads and prints the generated Order of

Payment through the ePortal and Email
notification.

124
Pays the assessed fee as per the system
generated Order of Payment Form through
the existing payment channels
1.2 Evaluates completeness and None 5 working FDA Evaluator
correctness of submitted days (Center/Licensing
documentary requirements. and Registration
Division)
1.3 Checks evaluation and veracity of None 4 working Technical Officer
documents submitted. days of Center

1.4 ality assurance of the evaluation. None 3 working Technical Officer

days of Center

1.5 Finalizes decision on the LTO None 2 Center Director

application working days

If application is disapproved, the

applicant will be notified through email
and will receive the Letter of Denial
2. Receives notification and link of LTO for None Qualified Person
printing
TOTAL: 14 working days

125
 1.25.LICENSE TO OPERATE – INITIAL APPLICATION FOR MANUFACTURERS OF HOUSEHOLD URBAN HAZARDOUS SUBSTANCES
(HUHS) BASED ON ADMINISTRATIVE ORDER NO. 2019-0019 AND FDA CIRCULAR 2020-025

Issuance of Electronic Portal (E-Portal) Ver.2.0 User Account

Center/Office/Division : Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Simple
Type of Transaction : G2B - Government to Business
Who may Avail : Manufacturers of Household/Urban Hazardous Substances (under Categories III and IV) based on AO 2019-
0019 and FDA Circular No. 2020-025
Fees to be paid : None

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1.Proof of Ownership of Establishment (refer to Annex B and B.1 of FDA Circular Applicant
No. 2020-025)

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1.6.1.1 Requests User Account credentials 1. Checks for the completeness and CCHUHSRR
by accomplishing the Online User’s appropriateness of the request None 15 Minutes Admin. Staff
Registration Form through the link:
bit.ly/ePortal2 (refer to Annex B.1)
2. Receives username and password 2. Issues user account (username and CCHUHSRR
password) to the client None Next Working Admin. Staff
Day
TOTAL: None 1 Working Day and 15 minutes

126
Center/Office/Division : Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Household/Urban Hazardous Substances (under Categories III and IV) based on
Administrative Order No. 2019-0019 and FDA Circular No. 2020-025
Fees to be Paid : Household Hazardous Substance Manufacturer:
1 Million and below - Php 1,000 + 1 % LRF
over 1 Million but below 5 Million - Php 2,000 + 1 % LRF
5 Million but below 10 Million - Php 3,000 + 1 % LRF
10 Million but below 20 Million - Php 5,000 + 1 % LRF`
20 Million but below 50 Million - Php 10,000 + 1 % LRF
50 Million and above - Php 15,000 + 1 % LRF

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the
Corresponding Services Rendered by the Bureau of
Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1) Basic Requirements based on the Administrative Order No. 2020-0017 and FDA Circular No. 2020-025: FDA website
(www.fda.gov.ph
Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portalv2
● Location plan and Global Positioning System (GPS) coordinates to be filled in the e-Application Form (https://eportal2.fda.gov.ph)

127
 ● Personnel information of the Authorized Person and Qualified Person of the establishment
● Self-Declaration in the e-Application Form
2) Proof of Business Registration
Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of Trade and
Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the Securities
and Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles of
Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with original charter,
or its Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of
Incorporation, if without original charter (1 Scanned copy PDF)

When a business or establishment address is different from the business name registration address, the
applicant shall submit a copy of the Business Permit (e.g. Mayor’s Permit).
3) Proof of income (Latest Audited Financial Statement with Balance Sheet) or Duly notarized
Statement/Certification of Initial Capitalization.
4) Payment of fees as prescribed by current FDA regulations (AO 50 s. 2001).

5) Site Master File (shall be presented to the FDA inspectors during inspection).
6) Risk Management Plan (shall be presented to the FDA inspectors during inspection)
7) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be presented to the FDA
inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE

128
 1. Access the FDA e-Portal V2 at 1. Pre-assessment on the FDA Evaluator
(https://eportal2.fda.gov.ph). Log in by completeness of application and
entering the issued username and documentary requirements
password submitted

In the Home tab, select New Application in

the navigation pane and click e-License to
Operate (Initial Application) to proceed to
the LTO application form.

Accomplish the application form as

provided in parts by the application wizard.
Fill-in the fields as completely as possible. None
Fields marked with a red asterisk (*) are
required to be filled-in. Mark required fields
with N/A, if not applicable.

Upload Documents in PDF format.

● Proof of Business Name Registration,
Proof of Income.Tick the box to certify all
information is true and correct, then “Next”.
Applicants may upload documents
simultaneously.

2. Pay the assessed fee as per the system 2.1 Post payment in ePortalv2 for Qualified Person
generated Order of Payment Form, confirmed payments. This will See above
through existing payment channels prompt automatic decking of table FDA Cashier
application to respective RFO

129
 Administrative
Posting of bank payment: and Finance
LBP OnColl Payment – 5 wd Service
Bancnet – 2 wd
2.2 Pre-license Inspection by Regional Regional Field
Field Offices (RFO) Officer/ Inspector

Refer to Regional Field Office *Not currently

Citizen’s Charter for the issuance required since
of Certificate of Compliance/ None HUHS
Recommendation for Disapproval/ manufacturer shall
Recommendation Letter also undergo PLI
(based on FDA
Advisory 2020-
2035)
2.3 Evaluation on the completeness FDA Evaluator
15 working (Center/Licensing
and veracity of the documents None
days and Registration)
submitted.
2.4 Checking of the evaluation and Technical Officer
veracity of documents submitted. None 3 working days of specific Center
of jurisdiction
2.5 Final Decision on the Approval of Center Director
LTO 2 working
None days
If application is disapproved, the
applicant will be notified through

130
 email and will receive the Letter of
Denial.

3 Receive notification and copy of e-LTO Qualified person

for printing
TOTAL: 20 working
days

131
1.26.LICENSE TO OPERATE – RENEWAL APPLICATION FOR MANUFACTURERS OF HOUSEHOLD URBAN HAZARDOUS SUBSTANCES
(HUHS) BASED ON ADMINISTRATIVE ORDER NO. 2019-0019 AND FDA CIRCULAR 2020-025

Issuance of Electronic Portal (E-Portal) Ver.2.0 User Account

Center/Office/Division : Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Simple
Type of Transaction : G2B - Government to Business
Who may Avail : All Manufacturers of Household/Urban Hazardous Substances (under Categories III and IV) based on AO 2019-
0019 and FDA Circular No. 2020-025
Fees to be paid : None

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1.Proof of Ownership of Establishment (refer to Annex B and B.1 of FDA Circular Applicant
No. 2020-025)

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Request User Account credentials by 1. Check for the completeness and CCHUHSRR
accomplishing the Online User’s appropriateness of the request None 15 Minutes Admin. Staff
Registration Form through the link:
bit.ly/ePortal2 (refer to Annex B.1)
2. Receive username and password 2. Issue user account (username and CCHUHSRR
password) to the client None Next Working Admin. Staff
Day
TOTAL: None 1 Working Day and 15 minutes

132
Center/Office/Division : Center for Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers Household Urban Hazardous Substances f Household/Urban Hazardous Substances (under
Categories III and IV) based on AO 2019-0019 and FDA Circular No. 2020-025
Fees to be Paid : Household Hazardous Substance Manufacturer:
1 Million and below - Php 2,000 + 10 % LRF
over 1 Million but below 5 Million - Php 4,000 + 1 % LRF
5 Million but below 10 Million - Php 6,000 + 1 % LRF
10 Million but below 20 Million - Php 10,000 + 1 % LRF
20 Million but below 50 Million - Php 20,000 + 1% LRF
50 Million and above - Php 30,000 + 1% LRF

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of
Food and Drugs
FDA Circular No. 2011-003
Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
FDA Circular No. 2011-004
Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering
License of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section
3, Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing
Rules and Regulations, and Other Purposes

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1)Basic Requirements based on the Administrative Order No. 2020-0017 and FDA Circular No.
2020-025:
133
 ● Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal V.2 (www.fda.gov.ph)
● Declaration and Undertaking Applicant / Qualified Person
2) Proof of payment of fees as prescribed by current FDA regulations (AO 50 s. 2001). FDA Cashier/Other FDA Authorized
Payment Portals or Banks
3) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be Applicant/Qualified person
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the FDA e-Portal V2 at 1. Pre-assessment on the completeness of None CCHUHSRR
(https://eportal2.fda.gov.ph). Log in by application and documentary Personnel
entering the issued username and requirements submitted
password.

Accomplish the LTO renewal application

form

Download and print the generated Order of

Payment through the ePortal and Email
notification.
2. Pay the assessed fee as per the system 2. Post payment in ePortalv2 for See above Qualified Person
generated Order of Payment Form confirmed payments. This will prompt table and FDA Cashier
through existing payment channels. automatic decking of application to Administrative
respective Center. and Finance
Service

2.1 Pre-Inspection by the Regional Field None Regional Field

Office (RFO)
134
 Officer/ Inspector
Refer to Regional Field Office Citizen’s
Charter for the issuance of Certificate of
Compliance/ Recommendation for
Disapproval/ Recommendation Letter
2.2 Evaluation on the completeness and None 3 working days FDA Evaluator
veracity of the documents submitted. (Center/Licensing
and Registration)
2.3 Checking of the evaluation and veracity None 2 working day Technical Officer
of documents submitted. of specific Center
of jurisdiction
2.4 Final Decision on the Approval of LTO None 2 working days Center Director
of jurisdiction
If application is disapproved, the applicant
will be notified through email and will
receive the Letter of Denial
3. Receive notification and copy of e-LTO None Qualified person
for printing
TOTAL: 7 working
days

135
 1.27.LICENSE TO OPERATE – MAJOR VARIATION FOR MANUFACTURERS OF HOUSEHOLD URBAN HAZARDOUS SUBSTANCES
(HUHS) BASED ON ADMINISTRATIVE ORDER NO. 2019-0019 AND FDA CIRCULAR 2020-025

Issuance of Electronic Portal (E-Portal) Ver.2.0 User Account

Center/Office/Division : Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Simple
Type of Transaction : G2B - Government to Business
Who may Avail : Manufacturers of Household/Urban Hazardous Substances (under Categories III and IV) based on AO 2019-
0019 and FDA Circular No. 2020-025
Fees to be paid : None

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1.Proof of Ownership of Establishment (refer to Annex B and B.1 of FDA Circular Applicant
No. 2020-025)

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
2.4.1.1 Request User Account credentials 1. Check for the completeness and CCHUHSRR
by accomplishing the Online appropriateness of the request None 15 Minutes Admin. Staff
User’s Registration Form through
the link: bit.ly/ePortal2 (refer to
Annex B.1)
2.4.1.2 Receive username and password 2. Issue user account (username and CCHUHSRR
password) to the client None Next Working Admin. Staff
Day
TOTAL: None 1 Working Day and 15 minutes

136
Center/Office/Division : Center for Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers of Household/Urban Hazardous Substances (HUHS)
Fees to be Paid : Amendment of LTO or Re-issuance (if lost) – Php 500 +1% LRF

Administrative Order 50 s. 2001* Revised 2001 Schedule of Fees and Charges for the Corresponding Services
Rendered by the Bureau of Food and Drugs

FDA Circular No. 2011-003

Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1) List of Requirements for Specific Variation based on Administrative Order No. 2020-0017: Qualified Person

A. Transfer of Location of Manufacturing Plant

Documentary Requirement:
1. Business permit reflecting the new address
2. Updated Site Master File to be presented upon inspection

B. Expansion of Manufacturer and/or Additional Product Line; or Change of Manufacturing

Activity
Documentary Requirement:
1.Updated Site Master File to be presented upon inspection

137
2 Proof of payment of fees as prescribed by current FDA regulations (AO 50 s. 2001). FDA Cashier/Other FDA Authorized
Payment Portals or Banks
3 Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be Applicant/Qualified person
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the FDA e-Portal V2 at 1. Pre-assessment on the None 0 Qualified Person
(https://eportal2.fda.gov.ph). Log in by entering completeness of application and
the issued username and password. documentary requirements
submitted
In the Home tab, select New Application in the
navigation pane and click e-License to Operate
(Variation Application) to proceed to the LTO
application form.

Accomplish the application form as provided in parts

by the application wizard. Fill-in the fields as
completely as possible. Fields marked with a red
asterisk (*) are required to be filled-in. Mark required
fields with N/A, if not applicable.

Upload Documents in PDF format.

● Proof of Business Name Registration,
Proof of Income. Tick the box to certify all
information is true and correct, then
“Next”.

138
Applicants may upload documents simultaneously.

Order of payment- A computer generated document

will appear reflecting the appropriate fees and
charges. Applicant should save and print a copy of
document as reference for payment
2. Pay the assessed fee as per the system 2.1 Post payment in ePortal V.2 for See above 0 Qualified Person/
generated Order of Payment Form through confirmed payments. This will table FDA Cashier
existing payment channels. prompt automatic decking of Administrative and
application to respective Center Finance Service
(AFS)

2.2 Pre-Inspection by Regional Field Regional Field

Office (RFO) Officer/ Inspector

Refer to Regional Field Office

None
Citizen’s Charter for the issuance
of Certificate of Compliance/
Recommendation for Disapproval/
Recommendation Letter
2.3 Evaluation of the correctness of None 15 working FDA Evaluator
submitted documentary days (Center/Licensing
requirements. and Registration
Division)

139
 2.4 Checking of the evaluation and None 3 working Technical Officer of
veracity of documents submitted. days specific Center of
jurisdiction
2.5 Approval of LTO None 2 working days Center Director of
jurisdiction
If the application is
disapproved, the applicant will
be notified through email and
will receive the Letter of Denial
3. Receives notification and copy of e-LTO for None Qualified Person
printing
TOTAL: 20 working days

140
1.28.LICENSE TO OPERATE – INITIAL APPLICATION FOR TRADERS, DISTRIBUTORS (IMPORTER, EXPORTER, WHOLESALER) OF
HOUSEHOLD URBAN HAZARDOUS SUBSTANCES (HUHS) BASED ON ADMINISTRATIVE ORDER NO. 2019-0019 AND FDA CIRCULAR
2020-025

Issuance of Electronic Portal (E-Portal) Ver.2.0 User Account

Center/Office/Division : Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Simple
Type of Transaction : G2B - Government to Business
Who may Avail : All Traders, Distributors (Importer, Exporter, Wholesaler) of Household/Urban Hazardous Substances (under
Categories III and IV) based on AO 2019-0019 and FDA Circular No. 2020-025
Fees to be paid : None

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1.Proof of Ownership of Establishment (refer to Annex B and B.1 of FDA Circular Applicant
No. 2020-025)

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Requests User Account credentials 1. Check for the completeness and CCHUHSRR
by accomplishing the Online User’s appropriateness of the request None 15 Minutes Admin. Staff
Registration Form through the link:
bit.ly/ePortal2 (refer to Annex B.1)
2. Receives username and password 2. Issue user account (username and CCHUHSRR
password) to the client None Next Working Admin. Staff
Day

141
 TOTAL: None 1 Working Day and 15 minutes

Center/Division : Center for Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B – Government to Business
Who May Avail : All Traders, Distributors (Importer, Exporter, Wholesaler) of Household Urban Hazardous Substances (under
Categories III and IV) based on AO 2019-0019 and FDA Circular No. 2020-025
Fees to be Paid : Household Hazardous Substances:
Importer, Exporter, Wholesaler- Php 3,000+ 1 % LRF
Note: The fees charged for the manufacturers and traders of products regulated by BFAD are based

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and
Drugs
FDA Circular No. 2011-003
Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended
by PD 1856
FDA Circular No. 2011-004
Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License of
Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3, Paragraphs
(A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing Rules and Regulations, and Other Purposes

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1)Basic Requirements based on the Administrative Order No. 2020-0017 and FDA Circular No. 2020- FDA e-Portalv2
025: (https://eportal2.fda.gov.ph)
● Location plan and Global Positioning System (GPS) coordinates to be filled in the e-Application Authorized Person
Form Qualified Person

142
 ● Personnel information of the Authorized Person and Qualified Person of the establishment
● Self-Declaration in the e-Application Form
2) Proof of Business Registration Applicant/Qualified Person
Any one of the following shall be submitted as proof of business name registration:
● For single proprietorship, the Certificate of Business Registration issued by the Department of
Trade and Industry (DTI) (1 Scanned copy PDF)
● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by
the Securities and Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy
PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles
of Cooperation (1 Scanned copy PDF)
● For Government-Owned or Controlled Corporation, the law creating the establishment, if with
original charter, or its Certificate of Registration issued by the Securities and Exchange
Commission (SEC) and Articles of Incorporation, if without original charter include Mayor’s Permit
or Barangay Clearance provision (1 Scanned copy PDF)
A copy of Business permit (i.e., Mayor’s Permit or Barangay Clearance provision) will be submitted for
business or establishment address with different business name registration address.
3) Proof of income (Latest Audited Financial Statement with Balance Sheet) or Duly notarized Applicant/Qualified person
Statement/Certification of Initial Capitalization.
4) Proof of payment of fees as prescribed by current FDA regulations (AO 50 s. 2001). FDA Cashier/Other FDA Authorized
Payment Portals or Banks
5) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be presented Applicant/Qualified person
to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE

143
 1. Access the FDA e-Portal V2 at Pre-assessment on the completeness FDA Evaluator
(https://eportal2.fda.gov.ph). Log in by of application and documentary
entering the issued username and requirements submitted
password

In the Home tab, select New Application in

the navigation pane and click e-License to
Operate (Initial Application) to proceed to the
LTO application form.

Accomplish the application form as provided

in parts by the application wizard. Fill-in the
fields as completely as possible. Fields None
marked with a red asterisk (*) are required to
be filled-in. Mark required fields with N/A, if
not applicable.

Upload Documents in PDF format.

● Proof of Business Name
Registration, Proof of Income. Tick
the box to certify all information is
true and correct, then “Next”.
Applicants may upload documents
simultaneously.
2. Pay the assessed fee as per the system 2.1 Post payment in ePortalv2 for Qualified Person
generated Order of Payment Form, confirmed payments. This will prompt
through existing payment channels See above
automatic decking of application to FDA Cashier
table
respective Center.

144
 Posting of Bank payment: Administrative
LBP OnColl Payment – 5 wd and Finance
Bancnet – 2 wd Service

2.2 Evaluation on the completeness and FDA Evaluator

veracity of the documents submitted. None 8 working days (Center/Licensing
and Registration)
2.3 Checking of the evaluation and Technical Officer
veracity of documents submitted. None 3 working days of specific Center
of jurisdiction
2.4 Final Decision on the Approval of Center Director
LTO of jurisdiction

None 3 working
If application is disapproved, the days
applicant will be notified through email
and will receive the Letter of Denial.
3. Receive notification and copy of e-LTO for Qualified person
printing
TOTAL: 14 working
days

145
 1.29.LICENSE TO OPERATE- RENEWAL APPLICATION FOR TRADERS, DISTRIBUTORS (IMPORTER, EXPORTER, WHOLESALER)
HOUSEHOLD URBAN HAZARDOUS SUBSTANCES (HUHS) BASED ON ADMINISTRATIVE ORDER NO. 2019-0019 AND FDA CIRCULAR
2020-025

Issuance of Electronic Portal (E-Portal) Ver.2.0 User Account

Center/Office/Division : Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Simple
Type of Transaction : G2B - Government to Business
Who may Avail : All Traders, Distributors (Importer, Exporter, Wholesaler) of Household/Urban Hazardous Substances (under
Categories III and IV) based on AO 2019-0019 and FDA Circular No. 2020-025
Fees to be paid : None

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1.Proof of Ownership of Establishment (refer to Annex B and B.1 of FDA Circular Applicant
No. 2020-025)

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
2.4.1.1 Request User Account credentials 1. Check for the completeness and CCHUHSRR
by accomplishing the Online User’s appropriateness of the request None 15 Minutes Admin. Staff
Registration Form through the link:
bit.ly/ePortal2 (refer to Annex B.1)
2.4.1.2 Receive username and password 2. Issue user account (username and CCHUHSRR
password) to the client None Next Working Admin. Staff
Day
TOTAL: None 1 Working Day and 15 minutes

146
Center/Division : Center for Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B – Government to Business
Who May Avail : All Traders, Distributors (Importer, Exporter, Wholesaler) Household Urban Hazardous Substances (under
Categories III and IV) based on AO 2019-0019 and FDA Circular No. 2020-025
Fees to be Paid : Household Hazardous Substances:
Importer, Exporter, Wholesaler - Php 6,000 + 1 % LRF

Administrative Order 50 s. 2001*

Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food
and Drugs
FDA Circular No. 2011-003
Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further Amended
by PD 1856
FDA Circular No. 2011-004
Computation of Surcharge or Penalty Impossible in case of Submission of Renewal Applications Covering License
of Establishments and Registration of Health Products After Their Date of Expiration Pursuant to Section 3,
Paragraphs (A)(2) and (B)(2) of Article I of Book II of the RA 9711 Implementing Rules and Regulations, and Other
Purposes

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1)Basic Requirements based on the Administrative Order No. 2020-0017 and FDA Circular No.
2020-025:
● Accomplished e-Application Form as prescribed by FDA regulations. FDA e-Portal V.2 (www.fda.gov.ph)
● Declaration and Undertaking Applicant / Qualified Person

147
2) Proof of payment of fees as prescribed by current FDA regulations (AO 50 s. 2001). FDA Cashier/Other FDA Authorized
Payment Portals or Banks
3) Refer to FROO Inspection Agenda of this Citizen’s charter for the documents that will be Applicant/Qualified person
presented to the FDA inspectors during inspection

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the FDA e-Portal V2 at 1. Pre-assessment on the None 0 FDA Evaluator
(https://eportal2.fda.gov.ph). Log in by completeness of application and
entering the issued username and documentary requirements
password. submitted

Accomplish the LTO renewal application form

Download and print the generated Order of

Payment through the ePortal and Email
notification.
2. Pay the assessed fee as per the system- 2.1 Post payment in ePortalv2 for See above 0 Qualified Person
generated Order of Payment Form through confirmed payments. This will table and FDA Cashier
existing payment channels. prompt automatic decking of Administrative
application to respective Center. and Finance
Service
2.2 Pre-Inspection by the Regional None Regional Field
Field Office (RFO) Officer/ Inspector

Refer to Regional Field Office

Citizen’s Charter for the issuance of
Certificate of Compliance/
148
 Recommendation for Disapproval/
Recommendation Letter
2.3 Evaluation on the completeness None 3 working days FDA Evaluator
and veracity of the documents (Center/Licensing
submitted. and Registration)
2.4 Checking of the evaluation and None 2 working day Technical Officer
veracity of documents submitted. of specific Center
of jurisdiction
2.5 Final Decision on the Approval of None 2 working days Center Director
LTO of jurisdiction

If application is disapproved, the

applicant will be notified through
email and will receive the Letter of
Denial
3. Receive notification and copy of e-LTO for None Qualified person
printing
TOTAL: 7 working days

149
1.30.LICENSE TO OPERATE – MINOR VARIATION APPLICATION FOR HOUSEHOLD URBAN HAZARDOUS SUBSTANCES (HUHS)
BASED ON ADMINISTRATIVE ORDER NO. 2019-0019 AND FDA CIRCULAR 2020-025

Issuance of Electronic Portal (E-Portal) Ver.2.0 User Account

Center/Office/Division : Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Simple
Type of Transaction : G2B - Government to Business
Who may Avail : All Manufacturers, Traders, Distributors (Importer, Exporter, Wholesaler) of Household/Urban Hazardous
Substances (under Categories III and IV) based on AO 2019-0019 and FDA Circular No. 2020-025
Fees to be paid : None

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1.Proof of Ownership of Establishment (refer to Annex B and B.1 of FDA Circular Applicant
No. 2020-025)

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
2.5.1.1 Request User Account 1. Check for the completeness and CCHUHSRR
credentials by accomplishing the appropriateness of the request None 15 Minutes Admin. Staff
Online User’s Registration Form
through the link: bit.ly/ePortal2 (refer
to Annex B.1)
2.5.1.2 Receive username and 2. Issue user account (username and None Next Working CCHUHSRR
password password) to the client Day Admin. Staff

TOTAL: None 1 Working Day and 15 minutes

150
Center/Office/Division : Cosmetic (and Household/Urban Hazardous Substances) Regulation and Research (CCHUHSRR)
Classification : Complex
Type of Transaction : G2B - Government to Business
Who May Avail : All Manufacturers, Traders, Distributors (Importer, Exporter, Wholesaler) of Household Urban Hazardous
Substances (under Categories III and IV) based on AO 2019-0019 and FDA Circular No. 2020-025
Fees to be Paid : Amendment of LTO or Re-issuance (if lost) – Php 500 +1% LRF
Administrative Order 50 s. 2001*
Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food
and Drugs
FDA Circular No. 2011-003
Collection of Legal Research Fee Imposed by Republic Act No. 3870, as amended by PD 200 and further
Amended by PD 1856
CHECKLIST OF REQUIREMENTS WHERE TO SECURE
1)List of Requirements for Specific Variation based on Administrative Order No. 2020-0017: Qualified Person

A. Transfer of Location Offices

- Physical transfer of the office of the establishment

Documentary Requirement:
1. Business permit reflecting new location of office
- Physical transfer of the office of the establishment

● For Single Proprietorship: Business Permit/ Mayor’s Permit or Barangay Business

Permit/ Clearance reflecting the new office location;
● For SEC-registered establishments:
a) Amended Articles of Incorporation (if transferred from one city/
municipality/province); or

151
 b) Updated General Information Sheet (GIS) from SEC (if transferred within the
same city/municipality/province)
● If the establishment address is different from the address indicated in the SEC
Registration, provide LGU/Mayor’s Permit or Barangay Business Permit/Clearance
reflecting new office location

B. Change of Distributor Activity

-additional/deletion or change in activity that the distributor is currently
engaged

Documentary Requirement:
1. Contract Agreements showing change in activity

C. Transfer or Addition of Warehouse

- Physical transfer and addition of warehouse of the establishment

Documentary Requirement:
1. Mayor’s Permit or Barangay Business Permit/Clearance reflecting new warehouse location

D. Expansion of Office Establishment

- expansion made which is adjacent to the existing location of the
establishment

Documentary Requirement:
a) Current floor plan
b) Expansion floor plan

E. Change of Ownership

152
 - Change in ownership of the licensed establishment

Documentary Requirement:
1. Business name registration reflecting new ownership
2. Any proof on the transfer of ownership
● Deed of sale or assignment or transfer of rights/ownership;
● Memorandum of Agreement; or
● Notarized Affidavit of the owner, proprietor, Chairman or CEO of the establishment
validating the transfer

F. Change of Business Name

- Change only in the business name of the establishment

Documentary Requirement:
1. Business name registration reflecting new business name.

G. Zonal Change in Address

- Change of the name/number of the street/building without physical transfer
of the establishment

Documentary Requirement:
1. Certificate of Zonal Address
2. Certification from Local Government Unit (City/Municipality) stating no physical transfer of
the establishment

H. Change of Qualified Person

- Change in the identified qualified person initially registered with the FDA

Documentary Requirement:
153
 1. Name of new qualified person, with credentials when applicable
2. Valid Professional Regulation Commission (PRC) ID
3. Signed Letter of Resignation duly noted by the former employer, if previously connected
with another pharmacy/establishment

I. Change of Authorized Person

- Change in the authorized person initially registered with the FDA

Documentary Requirement:
1. Name of new qualified person
2. Valid Government ID
2) Proof of payment of fees as prescribed by current FDA regulations (AO 50 s. 2001). FDA Cashier/Other FDA Authorized
Payment Portals or Banks

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the FDA e-Portal V2 at 1. Pre-assessment on the None Qualified Person
(https://eportal2.fda.gov.ph). Log in by entering completeness of application and
the issued username and password. documentary requirements
submitted
In the Home tab, select New Application in the
navigation pane and click e-License to Operate
(Variation Application) to proceed to the LTO
application form.

Accomplish the application form as provided in parts

by the application wizard. Fill-in the fields as
completely as possible. Fields marked with a red
154
asterisk (*) are required to be filled-in. Mark required
fields with N/A, if not applicable.

Upload Documents in PDF format.

● Proof of Business Name Registration, Proof
of Income. Tick the box to certify all
information is true and correct, then “Next”.
Applicants may upload documents simultaneously
Order of payment- A computer generated document
will appear reflecting the appropriate fees and
charges. Applicant should save and print a copy of
document as reference for payment
2. Pay the assessed fee as per the system 2.1 Post payment in ePortal V.2 for See Qualified Person
generated Order of Payment Form through confirmed payments. This will above and FDA Cashier
existing payment channels prompt automatic decking of table Administrative and
application to respective Center Finance Service
(AFS)
2.2 Evaluation of correctness of None 3 working FDA Evaluator
submitted documentary days (Center/Licensing
requirements. and Registration
Division)
2.3 Checking of the evaluation and None 2 working Technical Officer of
veracity of documents days specific Center of
submitted. jurisdiction
2.4 Approval of LTO None 2 working days Center Director of
jurisdiction

155
 If application is disapproved,
the applicant will be notified
through email and will receive
the Letter of Denial
3. Receive notification and copy of e-LTO for printing None Qualified Person

TOTAL: 7 working days

Note:
1. The fees charged for manufacturers and traders of products regulated by FDA are based on the capital invested.
2. Renewal of HUHS LTO shall be valid for a maximum period of five (5) years.
3. Application for renewal shall be done within three (3) months prior to validity date of the LTO. Applications filed after the validity
date of the LTO shall be subject to surcharge as prescribed in RA 9711 and its IRR.

156
1.31.LICENSE TO OPERATE – INITIAL APPLICATION FOR HOUSEHOLD/URBAN PEST CONTROL OPERATORS (PCO)

Center/Office/Division : Cosmetic and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR)
Classification : Highly Technical
Type of Transaction : G2B - Government to Business
Who May Avail : Pest Control Operators engaged in commercial, in-house, and government service application of
Household/Urban Pesticide Products
Fees to be Paid : Administrative Order No. 2019 – 0010, Annex E
Initial application – 6,000.00 php
Renewal application – 3,000.00 php
Variation application – 1,000.00 php

The above fees are subject to a legal research fund (LRF) equivalent to Php 10.00 or 1% of the application fee,
whichever is higher, as imposed by RA 3870, as amended by PD 200 and further amended by PD1856, and
surcharges and penalties for renewal applications filed beyond the validity date in accordance with RA 9711

CHECKLIST OF REQUIREMENTS WHERE TO SECURE

1)Basic Requirements based on the Administrative Order No. 2019-0010 Annex B:
Accomplished e-Application Form as prescribed by FDA regulations. FDA eServices (www.fda.gov.ph)
 Declaration and undertaking of the responsibilities of the applicant as a condition for the
processing and approval of the LTO; Applicant/Qualified person
 The location plan and global position system (GPS) coordinates of the establishment; Applicant/Qualified person
 The name and credentials of the FDA-certified supervising pesticide handler Applicant/Qualified person
2) Proof of Business Registration Applicant/Qualified person
Any one of the following shall be submitted as proof of business name registration (in pdf):
● For single proprietorship, the Certificate of Business Registration issued by the Department of
Trade and Industry (DTI) (1 Scanned copy PDF)

157
 ● For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by
the Securities and
Exchange Commission (SEC) and Articles of Incorporation (1 Scanned copy PDF)
● For Cooperative, the Certificate of Registration issued by the Cooperative Authority and Articles
of Cooperation (1 Scanned copy PDF)

In cases of inconsistencies with the business name and/or address, the following supporting documents
must be submitted:
- If the Business Name is different from the Corporate Name, the SEC Certificate must reflect:
''Doing business under the name and style of (Name of Establishment)"
- Valid Mayor's Business Permit or Barangay Business Permit, if the business name and
address is different from the registered name and address in the DTI or SEC

3) Notarized Agreement with a DOH-accredited health facility that will conduct annual medical check- Applicant/Qualified person
up for its supervising pesticide handlers, pesticide handlers and other personnel

4) Risk Management Plan (contingency plan) and procedures for handling accidents and emergencies, Applicant/Qualified person
and referrals to hospitals in case of accidents or casualties

5) Safety training plan for supervising pesticide handlers, pesticide handlers and other personnel Applicant/Qualified person

6.) Names and ID of the FDA-certified supervising pesticide handlers, pesticide handlers and other Applicant/Qualified person
personnel (per branch or office) 1

1
In the absence of availability of FDA-accredited trainings for SPH and PH, the PCO establishment shall submit copies of any proof of attendance to training/s of their SPH and PH related to
household/urban pest management issued by: (1) the Fertilizer and Pesticide Authority (FPA) following FDA Circular No. 2016-008; or (2) any reputable organizations within the last five (5)
years, in lieu of the required copy of ID of FDA-certified SPH and PH.
158
7.) If the owner/manager is not the FDA-certified supervising pesticide handler, submit written Applicant/Qualified person
authorization from the appointed FDA-certified supervising pesticide handler and Certificate of
Employment

8.) Payment of prescribed fee FDA Cashier/Other FDA

Authorized Payment Portals or Banks
9.) In cases when less than the required number of certified supervising pesticide handler is employed Applicant/Qualified person
by the pest control operator, the Standard Operating Procedure on the conduct of in-person and remote
supervision of pest control activities in multiple branches.

CLIENT STEPS AGENCY ACTION FEES TO PROCESSING PERSON

BE PAID TIME RESPONSIBLE
1. Access the online application portal through 1. Conducts pre-assessment on the FDA Pre-
(http://eservices.fda.gov.ph) and click “Applications submitted application based on the Assessor
“ found at the upper right corner of the system. completeness of the documents (Center/
submitted in accordance with the Licensing and
Proceeds to the Initial Application requirements Registration)

Reads the “Declaration and Undertaking” before If complete, an Order of Payment

proceeding with the application process. Check the
will be generated and will be given None
box “I agree to the Declaration and Undertaking”
and click on “Start Application”. to the client thru the eServices and
Email notification.
Uploads the required documents as indicated on the
Checklist of Requirements (ex. Proof of Business If incomplete, the application will
Name Registration with DTI/SEC) in pdf format.
not be received and will be
File size should not be more than 2MB (per
document requirement) returned to the client. A Pre-
assessment Letter of Disapproval

159
Reviews the duly filled out form in the Self- will be given to the client thru
Assessment Review. By agreeing to the Terms eServices and Email notification.
and Conditions, the applicant confirm the
completeness, correctness, and accuracy of the
information given. Click on “Confirm” to submit
the application.

Prints the Order of Payment with Reference Number

sent through the declared e-mail address
2. Pays the application fee through existing payment 2.1 Posts payment in eServices FDA Cashier
channels. Portal System for confirmed Administrative
payments. This will prompt and Finance
Receives Acknowledgment Receipt through email automatic decking of application to
Service (AFS)
respective Center.

LBP OnColl Payment: 5 wd

Other Payment Channels: 2 wd See above
table
Note: Acknowledgement Receipt
will automatically be sent to the
client once payment is posted and
will signify the start of processing
time of the application.

2.2 Evaluates the correctness of 12 working Food-Drug

the documents None days Regulation
Officer

160
 2.3 Checks the evaluation and 5 working days Food-Drug
veracity of the documents Regulation
submitted. Officer
3. Receives an application status through e-mail 3. Approval of LTO 3 working days Center Director
confirming that the application has been
evaluated and queued for final decision. If the application is disapproved,
None
the applicant will be notified
through email and will receive the
Letter of Disapproval
4. Receives an email notification containing the Qualified Person
system-generated LTO through the declared e-
mail address for printing.
TOTAL: 20 working days

161